VASCULAR
Document Sample


® / TM = Registered Trademark or Trademark of C. R. Bard, Inc.
U.S. PRODUCT MATRIX
VASCULAR
ELECTROPHYSIOLOGY
BARD ELECTROPHYSIOLOGY DIVISION Customer Service: 800-824-8724 Website: www.bardep.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
THERAPEUTIC CATHETERS, DIAGNOSTIC CATHETERS AND RECORDING SYSTEMS
Intracardiac Therapeutic Electrode Catheters: Steerable ablation catheters which use high frequency RF energy to These products are indicated for creating focal endocardial lesions during cardiac Direct to Hospital Electrophysiologist
STINGER® Catheter and SCORPION® 2 Catheter create a thermal lesion within the heart to treat cardiac arrhythmias. ablation procedures, as well as for cardiac electrophysiological mapping and
delivering diagnostic pacing stimuli.
Intracardiac Diagnostic and Mapping Electrode Catheters: Fixed curve and steerable catheters are used to locate the Steerable catheters have advanced steering mechanism providing superior Direct to Hospital Electrophysiologist
WOVEN™, WOVENFLEXIE™, VIKING™, VIKING SOFT TIP™, TANGO®, anatomical site causing abnormal cardiac activity, thereby providing positioning for mapping arrhythmias. Fixed and steerable catheters provide
DYNAMIC TIP™, XT™, EPXT®, ORBITER®, ORBITER ST™, ORBITER diagnostic assessment. superior stability and control.
PV™ Catheters, RADIA™, RADIA™ XT, and CONFORMA®
Catheter
Computerized EP Lab Recording System: Analyze and display of electrograms for assessment of heart's System delivers superior signal quality and unique 3D electrical activity maps for Direct to Hospital Electrophysiologist
LABSYSTEM™ PRO EP Recording System with ELECTROVIEW® 3D electrical conduction system to determine cause and location of improved accuracy of diagnosis through state-of-the-art electronics and computer CFO
mapping feature (EPLOGIX® Mapping & Analysis Suites), cardiac arrhythmias. software. It allows for enhanced user interface for improved patient assessment, Materials
ELECTRONAV™ (not yet released), EPLINK™ H.I.S. Interface, superior electrogram signal processing and analysis along with 3D mapping Management
CLEARSIGN® Amplifier, MicroPace Stimulator, STIMLAB™ Dual capabilities that gives a new approach to electrogram analysis with time and IT Administration
Touch Stimulation System, and STIMCOR™ frequency domain algorithms and 3D visualization. The STIMLAB™ is a unique Lab Manager
bedside stimulation option for improved lab through put. Nurses
Techs
Transvenous Temporary Pacing Electrode Catheters: Transmit electric stimuli to the heart to maintain its pacing function Gives physician excellent torque reliability and patient stability; soft tip helps Direct to Hospital Cardiologists
NBIH® Catheter, GOETZ® Catheter, Semi-Floating, Balloon in critical situations. ensure an atraumatic placement. ER
Bipolar, ZUCKER™ & MYLER™ Lumen, and GORLIN™ Catheters ICU
CCU
Intracardiac Access Products: Facilitates intracardiac catheterization for both right- and left-sided The CHANNEL™ Steerable Sheath provides CURVELOCK™ for exceptional stability. Direct to Hospital Electrophysiologist
CHANNEL™ Steerable Sheath, EZCROSS™ Introducer Kit (pending cardiac ablation procedures and device implant procedures. The EZCROSS™ Introducer Kit provides an excellent crossing profile for
510k clearance), TSX™ Transseptal Needle, BARD® SSV Split transseptal access with the TSX™ Needle, while the BARD® SSV and
Sheath with Valve, and the SAFESHEATH® ULTRA SAFESHEATH® ULTRA provide a proprietary splittable hemostasis valve.
Revised 03-07-11 Page 1 of 24
U.S. PRODUCT MATRIX
VASCULAR
GRAFTS
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
Tapes Indicated for the purposes of tissue approximation, retraction, and Available in both PTFE and polyester. Ranging in width from 1/16" to 3/16" and in Direct to Hospital Cardiovascular
as a temporary or permanent ligature. length from 24" to 36". BARD® PARSONNET™ Pulse Generator Pouches are also Surgeon
included in this category and are available in small, large and x-large versions. General Surgeon
Vascular Surgeon
ePTFE Patch Indicated for use in repair and closure of the cardiovascular system. Wide range of shapes and sizes to meet individual patient needs. Direct to Hospital Cardiovascular
Surgeon
General Surgeon
Vascular Surgeon
Shunts: Designed to be a temporary blood conduit in the carotid arteries Wide range of shapes and sizes to match individual patient needs. Direct to Hospital Vascular Surgeon
BARD® Carotid Bypass Shunt, BARD® JAVID™ Carotid Bypass during a carotid endarterectomy procedure. Cardiovascular
Shunt, BARD® BRENER™ Carotid Bypass Shunt, BARD® BURBANK™ Surgeon
Carotid Bypass Shunt General Surgeon
BARD® PARSONNET™ Vascular Probe Designed for use during coronary artery and peripheral vascular Special reviews for probes. Atraumatic occlusion with accurate assessment Direct to Hospital Vascular Surgeon
surgery. capabilities. Cardiovascular
Surgeon
General Surgeon
VASCULAR GRAFTS
IMPRA® ePTFE Vascular Grafts, CARBOFLO® Vascular Grafts Intended for use as subcutaneous arteriovenous conduits for blood Wide range of ePTFE graft designs to meet individual patient needs. C ARBOFLO® Direct to Hospital Vascular Surgeon
access, bypass, or reconstruction of peripheral arterial blood graft luminal wall is impregnated with carbon. General Surgeon
vessels. Transplant Surgeon
Nephrologist
Cardiovascular
Surgeon
DISTAFLO® & DYNAFLO® Peripheral Bypass Grafts Intended for bypass or reconstruction of peripheral arterial blood Proprietary ePTFE cuffed graft technology designed to improve hemodynamics Direct to Hospital Vascular Surgeon
vessels. through a vascular graft. Cuff on distal end. General Surgeon
Cardiovascular
Surgeon
VENAFLO® II ePTFE Vascular Access Grafts, VECTRA® Vascular Indicated for use as subcutaneous arteriovenous conduits for blood The VENAFLO® graft has proprietary ePTFE cuffed graft technology. The V ECTRA® Direct to Hospital Vascular Surgeon
Access Grafts access only. graft has innovative material allowing hemodialysis access within 24 hours after General Surgeon
implant. Transplant Surgeon
Nephrologist
Cardiovascular
Surgeon
Revised 03-07-11 Page 2 of 24
U.S. PRODUCT MATRIX
VASCULAR
GRAFTS
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
VASCULAR GRAFTS (Cont'd)
Textile Vascular Grafts and Fabrics: The knitted and woven polyester fabrics (BARD® SAUVAGE® Wide range of knitted and woven textile designs to meet individual patient needs. Direct to Hospital Cardiovascular
Textile Vascular Grafts, BARD® DEBAKEY® and BARD® SAUVAGE® Filamentous fabrics, BARD® DEBAKEY® Double Velour fabrics, Surgeon
Woven and Knitted Graft Products BARD® DEBAKEY® Elastic Knit fabrics, BARD® DEBAKEY® Woven General Surgeon
fabrics) are indicated for use in cardiovascular surgical procedures Vascular Surgeon
requiring patch graft angioplasty such as carotid endarterectomy.
These fabrics are also indicated for repair of certain intracardiac
anaomalies such as septal defects.
Woven and Knitted Vascular Protheses For replacement or bypass procedures in aneurysmal and occlusive Wide range of shapes and sizes to meet individual patient needs. Direct to Hospital Cardiovascular
disease of the abdominal aorta, visceral arteries, and proximal Surgeon
peripheral arteries, exclusive of the coronary arteries. General Surgeon
Vascular Surgeon
Fabrics DEBAKEY® Woven Fabrics and Edwards Outflow Tract Fabrics are Wide range of shapes and sizes to meet individual patient needs. Direct to Hospital Cardiovascular
indicated for aortic and pulmonary outflow tract repair and repair of Surgeon
intracardiac defects. General Surgeon
Vascular Surgeon
Felts Used in various applications for general, vascular, and cardiac Wide range of shapes and sizes to meet individual patient needs. Direct to Hospital Cardiovascular
surgery. Commonly used as a patch or buttress for sutures, and as Surgeon
a material for replacement segments of the ventricular myocardium General Surgeon
after resection. Vascular Surgeon
Pledgets Used as buttresses under sutures when there is a possibility of Wide range of shapes and sizes to meet individual patient needs. Direct to Hospital Cardiovascular
sutures tearing through tissue. They are used in various surgical Surgeon
suturing procedures, such as vascular closure, septal repair, General Surgeon
myocardial closure, hepatic repair, and valvular suturing. Vascular Surgeon
Revised 03-07-11 Page 3 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
ENDOLUMINAL PRODUCTS
PTA Balloons: The RIVAL® PTA Balloon Dilatation Catheter is intended to dilate CHECKER™ Flex Points for unrivaled trackability. Direct to Hospital Interventional
RIVAL® PTA Dilatation Catheter stenosis in the peripheral arteries, treat obstructive lesion of native Radiologists
or synthetic AV fistulae, and/or re-expand endoluminal stent graft Vascular Surgeons
elements in the iliac arteries. Interventional
Cardiologists
Interventional
Nephrologists
PTA Balloons: The VASCUTRAK™ PTA Dilatation Catheter is intended to dilate Two external wires provide focused force angioplasty for low inflation pressure Direct to Hospital Interventional
VASCUTRAK™ PTA Dilatation Catheter stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, dilatation. Lengths up to 300mm. Radiologists
and renal arteries and for the treatment of obstructive lesions of Vascular Surgeons
native or synthetic arteriovenous dialysis fistulae. Interventional
Cardiologists
Interventional
Nephrologists
PTA Balloons: BARD DIVISION/PRODUCTS USES
CONQUEST® PTA Balloon Dilatation Catheter is recommended for SPECIAL FEATURES
Ultra non-compliant balloon concentrates the outward force at the resistant lesion. Direct to Hospital Interventional
CONQUEST® PTA Balloon Dilatation Catheter use in Percutaneous Transluminal Angioplasty of the femoral, iliac, Radiologists
and renal arteries and for the treatment of obstructive lesions of Vascular Surgeons
native or synthetic arteriovenous dialysis fistulae. This device is Interventional
also recommended for post-dilatation of the F LAIR® Endovascular Cardiologists
Stent Graft. This catheter is not for use in coronary arteries. Note: Interventional
The FLAIR® Endovascular Stent Graft is only available in the United Nephrologists
States.
Revised 03-07-11 Page 4 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES
USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
ENDOLUMINAL PRODUCTS (Cont'd)
PTA Balloons: The ATLAS® PTA Balloon Dilatation Catheters are indicated for use Ultra non-compliant large diameter balloon with the highest working range on the Direct to Hospital Interventional
ATLAS® Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty of the iliac arteries and market Radiologists
for the treatment of obstructive lesions of native or synthetic Vascular Surgeons
arteriovenous dialysis fistulae. This catheter is not for use in Interventional
coronary arteries. Cardiologists
Interventional
Nephrologists
PTA Balloons: ULTRAVERSE® 014 and ULTRAVERSE® 018 PTA Dilatation Catheters Feature proprietary technologies including ULTRA-CROSS™ Dual Layer Hydrophilic Direct to Hospital Interventional
ULTRAVERSE® 014 and 018 PTA Dilatation Catheters are recommended for use in percutaneous transluminal angioplasty Coating, reinforced inner shaft and CHECKER™ Flex Points for optimal performance Radiologists
(PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. in distal peripheral anatomy. Vascular Surgeons
These catheters are not for use in coronary arteries. Interventional
Cardiologists
Interventional
Nephrologists
PTA Balloons: DORADO® Balloon Dilatation Catheters are recommended for Ultra non-compliant balloon with CHECKER™ Flex Points for improved trackability Direct to Hospital Interventional
DORADO® PTA Balloon Dilatation Catheter Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, with excellent deflation times and balloon lengths up to 200 mm. Radiologists
femoral, popliteal, tibial, peroneal, and subclavian arteries and for Vascular Surgeons
the treatment of obstructive lesions of native or synthetic Interventional
arteriovenous dialysis fistulae. This device is also recommended Cardiologists
for postdilatation of balloon expandable and self expanding stents in Interventional
the peripheral vasculature. This catheter is not for use in coronary Nephrologists
arteries.
Self Expanding Stents: The BARD® E-LUMINEXX® Vascular Stent is indicated for the Designed for exceptional visibility under fluoroscopy, which significantly enhances Direct to Hospital Interventional
E-LUMINEXX® Vascular Stent treatment of iliac occlusive disease in patients with symptomatic stent placement accuracy. Unique, multi-step electro-polishing technology Radiologists
vascular disease of the common and/or external iliac arteries up to reduces microscopic burrs and microcracks and enhanced surface finish improves Vascular Surgeons
126 mm in length with a reference vessel diameter of 5 to 9 mm. corrosion resistance. PERFORMAXX® Grip offers ease-of-use and excellent Interventional
deployment accuracy. Proven STENTLOC® Mechanism designed to assure Cardiologists
deployment accuracy in addition to the proven 6F BARD S.A.F.E.®* Delivery
System. "Tipless" Catheter proprietary design which reduces potential for stent
snagging.
Revised 03-07-11 Page 5 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
ENDOLUMINAL PRODUCTS (Cont'd)
Self Expanding Stents: The LIFESTENT® Vascular Stent Systems are intended to improve Multi-Dimensional helical architecture which is designed for and proven in the Direct to Hospital Interventional
LIFESTENT® Vascular Stent Systems luminal diameter in the treatment of symptomatic de-novo or Superficial Femoral Artery and Proximal Popliteal Artery. It is the only FDA Radiologists
restenotic lesions up to 160 mm in length in native superficial approved 170 mm Vascular Stent. Vascular Surgeons
femoral artery (SFA) and/or proximal popliteal artery with reference Interventional
vessel diameters ranging from 4.0-6.5 mm. Cardiologists
Stent Grafts: The FLAIR® Endovascular Stent Graft is indicated for use in the The FLAIR® Endovascular Stent Graft is the only endovascular intervention proven Direct to Hospital Interventional
FLAIR® Endovascular Stent Graft treatment of stenoses at the venous anastomosis of ePTFE or other in a controlled clinical trial to improve AV graft function over the current standard Radiologists
synthetic arteriovenous (AV) access grafts. of care. The flared outflow configuration optimizes flow in anatomies where the Vascular Surgeons
vein diameter is larger than the graft. Two-layer ePTFE (expanded Interventional
polytetrafluoroethylene) encapsulation reduces the incidence of restenosis in the Nephrologists
treatment area. Proprietary inner surface carbon impregnation technology is
designed to decrease platelet accumulation in the acute phase after implantation.
CROSSER™ Catheter The CROSSER™ System is indicated to facilitate the intra-luminal BARD® Over the Wire and Rapid Exchange CROSSER™ Catheters utilize high- Direct to Hospital Interventional
placement of conventional guidewires beyond peripheral artery frequency, mechanical vibration to enable central lumen crossing of CTOs, Radiologists
chronic total occlusions. allowing for subsequent balloon angioplasty, atherectomy and/or stent placement. Vascular Surgeons
Interventional
The CROSSER™ Catheter is only intended for use with the CROSSER™ Cardiologists
Electronics System. Refer to the C ROSSER™ Electronics System
Manual of Operations for proper use.
MICROSHEATH® XL Support Catheters MICROSHEATH® XL are single lumen catheters intended to create a MICROSHEATH® XL catheters provide excellent support and steerability for Direct to Hospital Interventional
pathway for other devices in the peripheral vasculature. CROSSER™ Catheter delivery. Supportive, thin wall technology allows for deep Radiologists
seating and distal support. The large inner lumen provides broad device Vascular Surgeons
compatibility, while the low profile tip design optimizes deliverability. Interventional
Cardiologists
Revised 03-07-11 Page 6 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES
SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
ENDOLUMINAL PRODUCTS (Cont'd)
PORTER® Guidewires PORTER® Guidewires are intended for use in the coronary and Providing exceptional CROSSER™ Catheter Support, Steerability and Visibility. Direct to Hospital Interventional
peripheral vasculature. Unique hydrophilic PORTER® Guidewire coating provides exceptional trackability Radiologists
even in the most tortuous anatomy. Various levels of tip stiffness of P ORTER® Vascular Surgeons
Guidewires provide precise steerability. A short radiopaque coiled tip provides Interventional
exceptional visibility without compromising placement of adjunctive devices. The Cardiologists
body of PORTER® Guidewires provides superb support for delivery of therapeutic
devices to the occlusion site.
CROSSER™ Generator The CROSSER™ Generator is intended for use only with the The CROSSER™ Generator and affixed Transducer convert AC power into high Direct to Hospital Interventional
CROSSER™ Catheter. frequency mechanical vibration, which is transferred to the C ROSSER™ Catheter. Radiologists
Vascular Surgeons
The CROSSER™ System is indicated to facilitate the intra-luminal The Generator mounts conveniently to a standard I.V. pole with no settings or Interventional
placement of conventional guidewires beyond chronic total adjustments required. A single foot switch activates the Generator, which emits Cardiologists
occlusions. an audible tone when activated.
FLOWMATE® Injector The FLOWMATE® Injector is indicated for use as a sterile saline The FLOWMATE® Injector provides unparalleled control, convenience, and system Direct to Hospital Interventional
injector for use as an accessory to the C ROSSER™ CTO integration to optimize CROSSER™ Catheter performance. Radiologists
Recanalization System. Vascular Surgeons
Interventional
Cardiologists
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION CLINICAL
Revised 03-07-11 Page 7 of 24
US DISTRIBUTION CLINICAL
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: http:://www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
NON-VASCULAR PRODUCTS
Self-Expanding Stents: The LIFESTENT® Biliary Stent System is intended for use in the Nitinol, helical stent with angled bridges helically aligned. Direct to Hospital Interventional
LIFESTENT® Biliary Stent palliation of malignant strictures (neoplasms) in the biliary tree. The Radiologists
safety and effectiveness of the LIFESTENT® Biliary Stent System's
stent diameter 8-10mm for use in the vascular system have not
been established.
Self-Expanding Stents: Self-expanding nitinol stents for the treatment of biliary strictures Designed for exceptional visibility under fluoroscopy, which significantly enhances Direct to Hospital Interventional
E-LUMINEXX® Biliary Stent resulting from malignant neoplasms. The safety and effectivess of stent placement accuracy. Unique, multi-step electro-polishing technology Radiologists
the device for use in the vascular system has not been reduces microscopic burrs and microcracks and enhanced surface finish improves
demonstrated. corrosion resistance. PERFORMAXX® Grip offers ease-of-use and excellent
deployment accuracy. Proven STENTLOC® Mechanism designed to assure
deployment accuracy in addition to the proven 6F BARD S.A.F.E.®* Delivery
System. "Tipless" Catheter proprietary design which reduces potential for stent
snagging.
Stent Grafts: Indicated for use in the treatment of tracheobronchial strictures FLUENCY® Plus Tracheobronchial Stent Graft: Nitinol stent framework Direct to Hospital Pulmonologists
FLUENCY® Plus Tracheobronchial Stent Graft produced by malignant neoplams. In the U.S., the safety and encapsulated in two layers of ePTFE. Radiopaque tantalum markers for Interventional
effectivess of the device for use in the vascular system has not enhanced visibility. The luminal surface of the ePTFE is carbon impregnated. Radiologists
been demonstrated, and can result in serious harm and/or death.
Balloon Expandable Stent: The VALEO® Biliary Stent is intended for use in the palliation of Direct to Hospital Interventional
VALEO® Biliary Stent malignant strictures (neoplasms) in the biliary tree. The safety and Radiologists
effectiveness of the device for use in the vascular system has not
been established.
Revised 03-07-11 Page 8 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
VASCULAR PRODUCTS
Vena Cava Filters: The SIMON NITINOL® Filter is indicated for use in the prevention of Low profile, two-level filtering, conical shape, MRI-compatible. Direct to Hospital Interventional
SIMON NITINOL® Filter recurrent pulmonary embolism via permanent placement in the Radiologists
vena cava in the following situations: Vascular Surgeons
º Pulmonary thromboembolism when anticoagulants are Trauma Surgeons
contraindicated General Surgeons
º Failure of anticoagulant therapy for thromboembolic disease Interventional
º Emergency treatment following massive pulmonary embolism Cardiologists
where anticipated benefits of conventional therapy are reduced
º Chronic, recurrent pulmonary embolism where anticoagulant
therapy has failed or is contraindicated
Vena Cava Filters: The G2® Femoral Delivery System is indicated for use in the Low profile, two-level filtering, conical shape, MRI-compatible. Direct to Hospital Interventional
G2® Filter prevention of recurrent pulmonary embolism via permanent Radiologists
placement in the vena cava in the following situation: Vascular Surgeons
º Pulmonary thromboembolism when anticoagulants are Trauma Surgeons
contraindicated General Surgeons
º Failure of anticoagulant therapy for thromboembolic disease Interventional
º Emergency treatment following massive pulmonary embolism Cardiologists
where anticipated benefits of conventional therapy are reduced
º Chronic, recurrent pulmonary embolism where anticoagulant
therapy has failed or is contraindicated
Revised 03-07-11 Page 9 of 24
U.S. PRODUCT MATRIX
VASCULAR
ENDOVASCULAR
BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardpv.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
VASCULAR PRODUCTS (Cont'd)
Vena Cava Filters: The ECLIPSE™ Filter is indicated for use in the prevention for Electropolished Finish. Direct to Hospital Interventional
ECLIPSE™ Vena Cava Filter recurrent pulmonary embolism via permanent placement in the Radiologists
vena cava in the following situations: Vascular Surgeons
º Pulmonary thromboembolism when anticoagulants are Trauma Surgeons
contraindicated General Surgeons
º Failure of anticoagulant therapy for thromboembolic disease Interventional
º Emergency treatment following massive pulmonary embolism Cardiologists
where anticipated benefits of conventional therapy are reduced
º Chronic, recurrent pulmonary embolism where anticoagulant
therapy has failed or is contraindicated
º ECLIPSE™ Filter may be removed according to the instructions
supplied under section labeled: Optional Procedure for Filter
Removal
Revised 03-07-11 Page 10 of 24
U.S. PRODUCT MATRIX
SURGICAL
SOFT TISSUE REPAIR
DAVOL INC. Customer Service: 800-556-6275 Websites: www.davol.com www.herniainfo.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
HERNIA/SOFT TISSUE REPAIR
PERFIX® Plug, PERFIX® Light Plug, KUGEL® Hernia Patch, MK™ Inguinal hernia repair Product for specific inguinal anatomy needs and surgical techniques. Tension-free Direct to Hospital General Surgeon
Patch, 3DMAX® Mesh, 3DMAX® Light Mesh, VISILEX® Mesh, repairs that minimize patient discomfort and allow rapid return to normal activity. andTthrough O.R. Supervisor
BARD® Mesh Flats and Pre-shapes, BARD® Soft Mesh, Distributors
SPERMATEX® Pre-shaped Mesh, BARD® Mesh Darts
VENTRIO™ Hernia Patch, COMPOSIX® L/P Mesh, COMPOSIX® E/X Ventral hernia repair Products to minimize dissection and the risk of tissue attachment to the Direct to Hospital and General Surgeon
Mesh, CK™ Ventral Patch, SEPRAMESHTM IP Composite, DULEX® prosthesis. Strong tissue ingrowth into polypropylene component. through distributors O.R. Supervisor
Mesh, RECONIX® Patch, BARD® PTFE Mesh, PRECISIONPASS®
Laparoscopic Delivery Device, VENTRALEX® Hernia Patch ,
VENTRALIGHT™ ST Mesh
CRURASOFT® Patch, CK™ Parastomal Hernia Patch Surgical specialty mesh Unique shapes and sizes designed for hiatal and parastomal hernia repair. Direct to Hospital and General Surgeon
Through Distributors O.R. Supervisor
ALLOMAX™ Surgical Graft Biologic grafts for soft tissue repair All natural, acellular human dermal collagen indicated for soft tissue repair. Direct to Hospital General Surgeon
O.R. Supervisor
COLLAMEND® FM Implant Biologic grafts for soft tissue repair All-natural and cross-linked acellular collagen matrix derived from porcine dermis Direct to Hospital General Surgeon
for soft tissue repair. O.R. Supervisor
XENMATRIX™ Surgical Graft Biologic grafts for soft tissue repair All natural and non-crosslinked acellular collagen matrix derived from porcine Direct to Hospital General Surgeon
dermis for soft tissue repair. O.R. Supervisor
FIXATION
SORBAFIX™ Absorbable Fixation System, PERMASORB® Disposable Fixation of prosthetics during soft tissue repair. Disposable fixation devices with absorbable PDLLA fasteners. Direct to Hospital General Surgeon
Fixation Device O.R. Supervisor
PERMAFIX™ Permanent Fixation System Fixation of prosthetics during soft tissue repair. Disposable fixation device with permanent polymer-based fasteners. Direct to Hospital General Surgeon
O.R. Supervisor
Revised 03-07-11 Page 11 of 24
U.S. PRODUCT MATRIX
SURGICAL
IRRIGATION
DAVOL INC. Customer Service: 800-556-6275 Websites: www.davol.com www.herniainfo.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
PERFORMANCE IRRIGATION PRODUCTS
SIMPULSE® Plus System, SIMPULSE® Solo Irrigation System Pulsed irrigation and suction for cleaning and debriding bone and Variable flow controls in hand piece; ease of set-up; always available as no Dealers Orthopaedic
soft tissues. mechanical pump system is required. Direct to Hospital Surgeon
O.R. Supervisor
SIMPULSE® VARICARE® Irrigation System Pulsed irrigation and suction for the debridment and treatment of Ease of set-up and use; high performance; cost effective. Dealers Surgeon
chronic wounds. Direct to Hospital O.R. Supervisor
Physical Therapist
ARTHRO-FLO® High Flow Irrigator, HYDROFLEX® Multi-Application Irrigation and joint distention during arthroscopic procedures. Ease of set-up; high performance. Dealers Orthopaedic
Irrigation System Controller, HYDROFLEX® AD Irrigation System Direct to Hospital Surgeon
O.R. Supervisor
X-STREAM® Irrigation System, ENDO-FLO® Irrigator, HYDROFLEX® LI Irrigation and suction during laparoscopic surgery. Ease of set-up, full line of pumps and probes for suction, irrigation, and Dealers Surgeon
Irrigation System, HYDROSURG® Plus Irrigation System, NEZHAT- electrosurgery. Direct to Hospital O.R. Supervisor
DORSEY® Probes
HYDROFLEX® Multi-Application Irrigation System Controller, Uterine distention, irrigation and fluid monitoring during Ease of set-up, pressure relief valve, controlled pressures, real-time deficit Dealers OB-GYN Surgeon
HYDROFLEX® HD Hysteroscopic Distention Tubing Set, AQUASENS® hysteroscopic procedures. monitoring. Direct to Hospital O.R. Supervisor
Fluid Monitoring System
HEMOSTASIS
AVITENE® Microfibrillar Collagen Hemostat, AVITENE® ULTRAFOAM® Control bleeding during surgery. An active collagen hemostat that accelerates clot formation. Dealers Surgeon
Collagen Sponge, ENDO-AVITENE®, SYRINGEAVITENE™, Non- Direct to Hospital O.R. Director
WOVEN Web Sheets, AVITENE® Flour Chief Pharmacist
Revised 03-07-11 Page 12 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
Biopsy
BARD BIOPSY SYSTEMS: A BUSINESS UNIT OF BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardbiopsy.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
BIOPSY PRODUCTS
Vacuum Assisted Biopsy: The FINESSE™ ULTRA Breast Biopsy System is indicated to obtain The FINESSE™ ULTRA Breast Biopsy System is the only self-contained, vacuum- Direct to Hospital Radiologists
FINESSE™ ULTRA Breast Biopsy System tissue samples from the breast or axillary lymph nodes for assisted, ultrasound-guided breast biopsy system with the ability to acquire Direct to Physician Interventional
diagnostic analysis of breast abnormalities. The instrument is multiple samples with a single probe insertion. With sample cycling time just 10 Radiologists
intended to provide breast tissue for histologic examination with seconds, the FINESSE™ ULTRA Breast Biopsy System acquires large, high-quality, Surgeons
partial or complete removal of the imaged abnormality. contiguous tissue samples rapidly from a single insertion. Its ultra sharp cutting tip
and optional piercing mode penetrate dense breast tissue and lesions accurately
without displacing the lesion.
Vacuum Assisted Biopsy: The VACORA® Breast Biopsy System is indicated to provide breast The VACORA® Vacuum Assisted Breast Biopsy System enables physicians to Direct to Hospital Radiologists
VACORA® Vacuum Assisted Breast Biopsy System tissue samples for diagnostic sampling of breast abnormalities. perform a minimally invasive breast biopsy while obtaining large, high-quality, Direct to Physician Interventional
The instrument is intended to provide breast tissue for histologic contiguous tissue samples. The system is easily used with ultrasound, Radiologists
examination with partial or complete removal of the imaged stereotactic x-ray, and MR image guidance. Surgeons
abnormality.
Vacuum Assisted Biopsy: The ENCOR® Breast Biopsy System is indicated to provide breast The ENCOR® Breast Biopsy System enables physicians to perform a minimally Direct to Hospital Radiologists
ENCOR® Breast Biopsy System tissue samples for diagnostic sampling of breast abnormalities. invasive breast biopsy while obtaining large, high-quality tissue samples. E NCOR® Direct to Physician Interventional
The instrument is intended to provide breast tissue for histologic Probe with TRICONCAVE™ cutting tip for smooth entry with an oscillating tubular Radiologists
examination with partial or complete removal of the imaged cutter for tissue acquisition. A completely closed system with detachable tissue Surgeons
abnormality. collection chamber. System includes fluid management saline rinse option as well
as patient comfort controls with anesthestic placement option. The pre-
programmed system has settings for dense tissue or half sample options.
Designed as a handheld unit for ultrasound guided biopsies, and for mounting on a
prone or upright table for stereotactic biopsies (compatible with Mammotest,
Lorad, Siemens GE, Giotto).
Vacuum Assisted Biopsy: The ENCOR® Breast Biopsy System for MRI is indicated to provide The ENCOR® MRI Biopsy System consists of the base unit plus a specially Direct to Hospital Radiologists
ENCOR® Breast Biopsy System for MRI breast tissue samples for diagnostic sampling of breast designed MRI-compatible handpiece and foot pedal. The ENCOR® Breast Biopsy Direct to Physician Interventional
abnormalities. The instrument is intended to provide breast tissue MRI Probe has a TRICONCAVE™ cutting tip for smooth entry or a blunt tip for use Radiologists
for histologic examination with partial or complete removal of the with an introducer set. The VISILOC™ MRI Introducer set contains a highly MRI Surgeons
imaged abnormality. visible obturator , a trocar and a locking grid block and locking cannula ensuring
stability in the MRI grid. Disposable ENCOR® MRI probes are longer, ensuring
easy placement either through the grid or through pillar/post systems.
Vacuum Assisted Biopsy: The SENOSONIX® II-t Utrasound Guided Breast Biopsy System is The SENOSONIX® II-t Biopsy System includes the ENCOR® Breast Biopsy System Direct to Hospital Radiologists
SENOSONIX® II-t Utrasound Guided Breast Biopsy System indicated to provide breast tissue samples for diagnostic sampling and Terason t3000 Ultrasound System. It is compatible with both the E NCOR® Direct to Physician Interventional
of breast abnormalities. The instrument is intended to provide and ENCOR® 360 Handpieces. The SENOSONIX® II-t Ultrasound Guided Breast Radiologists
breast tissue for histologic examination with partial or complete Biopsy System combines a quality biopsy system with a portable, laptop-size, Surgeons
removal of the imaged abnormality. battery operated ultrasound system.
Vacuum Assisted Biopsy: The ENCOR® 360 Breast Biopsy device is indicated to acquire The ENCOR® 360 is a 9 Gauge Circumferential Vacuum Assisted Biopsy Device Direct to Hospital Radiologists
ENCOR® 360 Circumferential Breast Biopsy Device tissue for diagnostic sampling of breast abnormalities. The and contains a sharp stainless steel tri-concave trocar tip for insertion and a Direct to Physician Interventional
instrument is intended to provide breast tissue for histologic rotating tubular blade for tissue acquisition. A detachable coaxial cannula is Radiologists
examination with partial or complete removal of the imaged provided for access to the biopsy site. Surgeons
abnormality.
Revised 03-07-11 Page 13 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
Biopsy
BARD BIOPSY SYSTEMS: A BUSINESS UNIT OF BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardbiopsy.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
BIOPSY PRODUCTS (Cont'd)
Vacuum Assisted Biopsy: The ENCOR® Fire Forward Accessory provides a mechanical The ENCOR® Fire Forward is used to automatically advance the ENCOR® Biopsy Direct to Hospital Radiologists
ENCOR® Fire Forward Accessory interface between the ENCOR® Breast Biopsy Handpiece and Probe tip into the lesion approximately 19 mm, using spring power. It is reusable Direct to Physician Interventional
various stereotactic tables. The ENCOR® Fire Forward is and affixes directly to the ENCOR® Breast Biopsy System Handpiece with a Radiologists
compatible with the Lorad, Fischer/Mammotest, GE, and Giotto mounting screw and two pins. Surgeons
stereotactic tables.
Breast Tissue Marker: The ULTRACLIP® Breast Tissue Markers is intended for use to attach The ULTRACLIP® Marker is designed for precision and ease of use. There are Direct to Hospital Radiologists
ULTRACLIP® Family of Breast Tissue Markers to soft breast tissue at the surgical site during an open surgical various shapes available for marking multiple sites within the same breast. Direct to Physician Interventional
breast biopsy or a percutaneous breast biopsy to radiographically Radiologists
mark the location of the biopsy procedure. Breast Surgeons
Breast Tissue Marker: The GEL MARK ULTRA™ Breast Tissue Markers are intended to The GEL MARK ULTRA™ Markers contain one wireform and 10 resorbable PLA/PGA Direct to Hospital Radiologists
GEL MARK ULTRA™ Family of Breast Tissue Markers radiographically mark breast tissue during a percutaneous biopsy pellets that are visible via ultrasound for approximately 6 weeks. Compatible with Direct to Physician Interventional
procedures. ENCOR®, ENCOR® 360, and Mammotome Breast Biopsy Devices. Radiologists
Breast Surgeons
Breast Tissue Marker: The GEL MARK ULTRACOR® Marker is intended to radiographically The GEL MARK ULTRACOR® Marker consists of a disposable applicator containing 5 Direct to Hospital Radiologists
GEL MARK ULTRACOR® Breast Tissue Marker and sonographically mark breast tissue prior to or during a resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets including one with Direct to Physician Interventional
percutaneous biopsy procedure. an embedded radiopaque stainless steel or titanium marker in the distal position. It Radiologists
can be used independently or in conjunction with a coaxial guide to access the Breast Surgeons
biopsy site.
Breast Tissue Marker: The ULTRACOR® Breast Tissue Marker is intended to ULTRACOR® Breast Biopsy Marker, 17 Guage consists of a disposable beveled Direct to Hospital Radiologists
ULTRACOR® Breast Tissue Marker radiographically mark breast tissue during a percutaneous biopsy needle Applicator containing one Stainless Steel radiographic coil wireform and 2 Direct to Physician Interventional
procedure. Polyethylene glycol (PEG) plugs in the distal and proximal positions. The Radiologists
Applicator has a beveled 10 cm/17G needle with 1 cm depth marks and a locking Breast Surgeons
plunger. The coil is deployed from the beveled needle tip into the tissue site.
Breast Tissue Marker: The SENOMARK® Breast Tissue Markers are intended to SENOMARK® Markers contain one stainless steel or titanium wireform in the center Direct to Hospital Radiologists
SENOMARK® Family of Breast Tissue Markers radiographically and sonographically mark breast tissue during a of 3 resorbable PGA pads and one PEG push pad at the proximal end that are Direct to Physician Interventional
percutaneous biopsy procedure. visible via ultrasound for approximately 3 weeks. Various shapes are available for Radiologists
marking multiple sites. Compatible with ENCOR®, Mammotome, ATEC, and Eviva Breast Surgeons
Breast Biopsy Devices.
Breast Tissue Marker: The SENOMARK ULTRACOR™ MRI Marker is intended to The SENOMARK ULTRACOR™ MRI Marker contains one stainless steel or titanium Direct to Hospital Radiologists
SENOMARK ULTRACOR™ MRI Breast Tissue Marker radiographically and sonographically mark breast tissue prior to or wireform in the center of 3 resorbable PGA pads and one PEG push pad at the Direct to Physician Interventional
during a percutaneous biopsy procedure. distal end that are visible via ultrasound for approximately 3 weeks. The Radiologists
applicator has a beveled 13cm/14G needle with 0.5 cm depth marks and a locking Breast Surgeons
plunger. The SENOMARK ULTRACOR™ MRI applicator is longer, ensuring easy
placement during an MRI biopsy procedure.
Breast Tissue Marker: The STARCHMARK® Breast Tissue Markers are intended to STARCHMARK® Breast Tissue Markers contain 6 resorbable polysaccharide (starch) Direct to Hospital Radiologists
STARCHMARK® Family of Breast Tissue Markers radiographically mark breast tissue during a percutaneous biopsy pellets, one PLA/PGA acid-based copolymer pelleted with an embedded stainless Direct to Physician Interventional
procedure. steel radiopaque wireform and one polyethylene glycol push pellet. Compatible Radiologists
with ENCOR® and Mammotome Breast Biopsy Devices. Breast Surgeons
Revised 03-07-11 Page 14 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
Biopsy
BARD BIOPSY SYSTEMS: A BUSINESS UNIT OF BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardbiopsy.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
BIOPSY PRODUCTS (Cont'd)
Breast Tissue Marker: The STARCHMARK ULTRACOR™ Breast Tissue Marker is intended to STARCHMARK ULTRACOR™ Markers contain 4 resorbable polysaccharide (starch) Direct to Hospital Radiologists
STARCHMARK ULTRACOR™ Breast Tissue Marker radiographically mark breast tissue during a percutaneous biopsy pellets, and one polyethylene glycol pellet with an embedded stainless steel Direct to Physician Interventional
procedure. radiopaque wireform. Can be used with ENCOR® MRI, ATEC MRI, ENCOR® and Radiologists
Eviva, using compatible introducers. Breast Surgeons
Breast Lesion Localization Wire: The GHIATAS® Localization Wire is intended for use during breast Three beads for easy visual reference. In addition, the beads offer palpable Direct to Hospital Radiologists
GHIATAS® Beaded Breast Localization Wire lesion surgery as a guide for the surgeon to follow in the excision of reference during the surgical excision of the lesion. MRI compatible versions are Direct to Physician Interventional
the lesion. available. Radiologists
Surgeons
Breast Lesion Localization Wire: The CHESBROUGH™ Breast Localization Wire is intended for use Incorporates the latest development in breast localization wires, dual-facing barbs, Direct to Hospital Radiologists
CHESBROUGH™ Breast Localization Wire during breast lesion surgery as a guide for the surgeon to follow in designed to minimize migration of the wire once it is placed. Bead between barbs Direct to Physician Interventional
the excision of the lesion. offers a visual and palpable reference and helps to minimize transection during Radiologists
excision of the suspected lesion. Surgeons
Breast Lesion Localization Wire: The ULTRAWIRE® Breast Localization Wire is intended for use during One-handed breast localization device allows for easy deployment. The needle Direct to Hospital Radiologists
ULTRAWIRE® Breast Localization Device breast lesion surgery as a guide for the surgeon to follow in the retracts into handle after the wire is deployed to minimize the risk of accidental Direct to Physician Interventional
excision of the lesion. needle sticks. Radiologists
Surgeons
Breast Lesion Localization Wire: The BARD® DUALOK® Breast Lesion Localization Wire is intended Exclusive BARD® DUALOK® Localization Wire features two curved locking elements Direct to Hospital Radiologists
BARD® DUALOK® Breast Lesion Localization Wire for use as a guide for directing surgical biopsies. that restrict the wire from being pushed forward or pulled out of its intended Direct to Physician Interventional
position. The wire is repositionable. Radiologists
Surgeons
Disposable Core Biopsy Instruments: The BARD® MAX-CORE® and BARD® MONOPTY® Disposable Core The BARD® MAX-CORE® Bipsy Instrument and BARD® MONOPTY® Biopsy Instrument Direct to Hospital Radiologists
BARD® MAX-CORE® Biopsy Instrument and BARD® MONOPTY® Biopsy Instruments are single-patient use, core biopsy devices are fully disposable biopsy instruments that are available in various gauge sizes Direct to Physician Interventional
Biopsy Instrument intended for use in obtaining biopsies from soft tissue; such as, and lengths. Radiologists
liver, kidney, prostate, breast, spleen, lymph nodes, and various Surgeons
soft tissue tumors.
Reusable Core Biopsy Instrument: The BARD® MAGNUM® Biopsy System is intended for use in BARD® MAGNUM® Biopsy System is the only reusable biopsy instrument featuring Direct to Hospital Radiologists
BARD® MAGNUM® Biopsy System obtaining biopsies from soft tissues; such as, liver, kidney, prostate, one-handed cocking plus a choice of two penetration depths. High velocity throw Direct to Physician Interventional
breast, spleen, lymph nodes, and various soft tissue tumors. and precise needle design help assure consistently excellent core samples. Radiologists
Surgeons
Disposable Coaxial Biopsy Needle: The BARD® TRUGUIDE® Coaxial Biopsy Needle is intended for use Only one gauge size larger than the BARD® core biopsy needles. Direct to Hospital Radiologists
BARD® TRUGUIDE® Coaxial Biopsy Needle as a guiding needle in obtaining core biopsy samples from soft Engineered specifically for use with the BARD® core biopsy needle instruments to Direct to Physician Interventional
tissues; such as, liver, kidney, spleen, lymph nodes, and various ensure compatibility and enhance accuracy. Radiologists
soft tissue tumors. Surgeons
Revised 03-07-11 Page 15 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
Biopsy
BARD BIOPSY SYSTEMS: A BUSINESS UNIT OF BARD PERIPHERAL VASCULAR, INC. Customer Service: 800-321-4254 Website: www.bardbiopsy.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
BIOPSY PRODUCTS (Cont'd)
Needle Guides: Accessory for Lorad MultiCare Platinum™ System. Direct to Hospital Radiologists
BARD® Needle Guides for Lorad MultiCare Platinum™ System Direct to Physician Interventional
Radiologists
Surgeons
Disposable Aspiration Biopsy Needle: The BARD® VACU-CUT® Disposable Aspiration Biopsy Needle is Exclusive sealing membrane inside winged hub provides the convenience of self- Direct to Hospital Radiologists
BARD® VACU-CUT® Disposable Aspiration Biopsy Needle intended for use in obtaining biopsies from soft tissues such as aspiration, creating a negative pressure when stylet is withdrawn. Direct to Physician Interventional
liver, kidney, prostate, spleen, lymph nodes, and various soft tissue Radiologists
tumors. Surgeons
Disposable Bone Biopsy Needle: The BARD® OSTYCUT® Biopsy Needle is intended for use in bone Threaded cannula and trocar point stylet facilitate easier penetration, while self- Direct to Hospital Interventional
BARD® OSTYCUT® Bone Biopsy Needle biopsy procedures. locking aspiration syringe helps assure easier specimen retrieval. Direct to Physician Radiologists
Sentinel Node Detection: The GAMMA FINDER® cordless probe is intended for the pre-operative The GAMMA FINDER® cordless probe provides an acoustic and visual signal when Direct to Hospital Surgeon
GAMMA FINDER® Cordless Probe and intraoperative detection of radioactive labeled substances. detecting gamma radiation. Direct to Physician Radiologist
Accelerated Partial Breast Irradiation: The CONTURA® MLB Catheter delivers targeted radiation to the Multi-lumen dose shaping optimizes treatment coverage and minimizes skin and Direct to Hospital Surgeon
CONTURA® Multiple Lumen Balloon ("MLB") Catheter tissue surrounding the lumpectomy cavity, rather than irradiating the rib dose providing the flexibility to treat more patients. Dealers Radiation Oncologist
entire breast. Medical Physicist
Medical Oncologist
Revised 03-07-11 Page 16 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
ONCOLOGY PRODUCTS
BARD ACCESS SYSTEMS, INC. Customer Service 800-545-0890 Website: www.bardaccess.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
SPECIALTY ACCESS
Chronic Catheters: Continuous access to the venous system for administration of Single, dual or triple lumen configurations; antimicrobial cuff creates a physical Direct to Hospital Surgeon
GROSHONG® Valved Catheters, HICKMAN®, BROVIAC®, LEONARD®, nutrients, drugs, and blood sampling. barrier to bacteria; GROSHONG® catheter technology featuring a unique three-way Oncologist
POWERHICKMAN®, POWERLINE®, POWERHOHN® Catheters valve. POWERHICKMAN®, POWERLINE®, and POWERHOHN® catheters allow for power Oncology Nurse
injection of contrast media for CECT scans. Interventional
Radiologist
Implantable Ports: Continuous access to the venous system for administration of BARD® ports feature the proprietery GROSHONG® catheter, which has a unique Direct to Hospital Surgeon
BARDPORT® Implantable Ports, X-PORT® Implantable Ports, SLIM nutrients, drugs, and blood sampling. The BARD® POWERPORT® three-way valve that eliminates the need for heparin as part of the care and Oncologist
PORT® Implantable Ports, M.R.I.® Implantable Ports, R OSENBLATT® device offers the unique ability to provide access for power injected maintenance of the port. The BARDPORT® Implantable Port features both single Oncology Nurse
Implantable Ports, X-PORT isp™ Implantable Ports, X-PORT DUO™ contrast media for CECT scans. and dual lumen configurations as well as multiple catheter types and materials, Interventional
Implantable Ports, X-PORT INLINE™ Implantable Ports, DOME including CHRONOFLEX® polyurethane, open-ended catheters; GROSHONG® silicone Radiologist
M.R.I.® POWERPORT® Implantable Ports, POWERPORT M.R.I.® valved catheters; and silicone open-ended catheters. BARD® POWERPORT® CT Department
Implantable Ports, POWERPORT® isp Implantable Ports, provides access to the venous system and also provides the capability to power Personnel
POWERPORT® SLIM Implantable Ports, POWERPORT® M.R.I® Duo inject contrast media for CECT scans common in cancer patients.
Implantable Ports, POWERPORT® Vue
POWERLOC®, POWERLOC® Clear, POWERLOC® MAX, POWERLOC® EZ Huber needles to access implantable ports for administration of POWERLOC®, POWERLOC® Clear, POWERLOC® MAX, POWERLOC® EZ power Direct to Hospital, Oncology Nurse
Power Injectable Safety Infusion Set, H UBERPLUS®, SAFESTEP®, nutrients, drugs, and blood sampling. Port Access kits provide a injectable safety infusion sets enable the BARD® POWERPORT® device to be safely Alternate Site Dealers IV Nurse
MINILOC®, LIFTLOC®, EZ Huber Safety Infusion Sets. Port Access convenient solution to promote "best practices" for port access injected with contrast media for CECT scans common in cancer patients. [The Infusion Centers Infusion Centers
Kits in POWERLOC®, POWERLOC® MAX, SAFESTEP® and MINILOC® related procedures. SAFESTEP® safety infusion set offers the non-power injectable Huber needle Physician Offices Physician Offices
Configurations design to both the hospital and non-hospital segments.] Port Access Kits
designed to standardize port access procedures.
Dialysis Catheters: Continuous access to the venous system for filtration of waste High flow dual lumen catheters for acute or chronic use; stepped and split tip Direct to Hospital Nephrologists
DUET®, EQUISTREAM®, HEMOSPLIT®, HEMOSTAR®, HEMOSPLIT® XK, products from blood in patients suffering from kidney failure. variations. BIOBLOC® silver sulfadiazine coating optional on HEMOSPLIT® and Dialysis Clinics Surgeon
HEMOSTAR® XK, HICKMAN®, and Soft-Cell® Long-Term HEMOSTAR® chronic dialysis catheters. POWER-TRIALYSIS® Short-Term Dialysis Nurse
Hemodialysis Catheters, POWER-TRIALYSIS®, NIAGARA®, NIAGARA® Hemodialysis catheter allows for power injection of contrast media for patients Interventional
SLIM-CATH®, and BREVIA® Short-Term Hemodialysis Catheters requiring CECT scans. Radiologist
Interventional
Nephrologist
Peripherally Inserted Central Catheters (PICCs); Midlines: Peripheral access to the central venous system for the Single lumen, dual lumen, and triple lumen configurations in small sizes allow for Direct to Hospital Oncology Nurse
POWERPICC SOLO®, POWERPICC®, POWERPICC® SV, POLY PER- administration of chemotherapeutic agents, antibiotics, and blood peripheral (arm) placement by nurses or physicians. POWERPICC SOLO®, Home Care IV Nurse
Q-CATH®, POLY RADPICC®, GROSHONG® Valved PICC Catheters, sampling. Many of the BARD® PICCs also allow for power injection GROSHONG®, and POWERGROSHONG® catheters allow for Heparin-optional flushing. Companies ICU Nurse
RADPICC®, GROSHONG® NXT, GROSHONG® NXT CLEARVUE® and of contrast media for CECT scans. Many of the BARD® PICCs also allow for power injection of contrast media for Home Care PICC Teams
POWERGROSHONG® Catheters CECT scans. Alternate Site Dealers Interventional
Independent Radiologist
Practitioners
Revised 03-07-11 Page 17 of 24
U.S. PRODUCT MATRIX
ONCOLOGY
ONCOLOGY PRODUCTS
BARD ACCESS SYSTEMS, INC. Customer Service 800-545-0890 Website: www.bardaccess.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
SPECIALTY ACCESS (Cont'd)
SHERLOCK® Tip Location System (TLS) Ultrasound System designed for vascular access using a needle Allows for vessel visualization and assessment of vessel patency prior to catheter Direct to Hospital PICC Nurse
guide or free-hand. placement. Home Care Interventional
Companies Radiologist
Home Care Nephrologist
Alternate Site Dealers Surgeon
Independent ICU Physician
Practitioners
SAPIENSTM Tip Confirmation System (TCS) Used to confirm PICC tip location in proximity to the caval atrial Used as an alternative to confirmatory chest X-ray for PICCs placed at the beside.
junction (CAJ). System is an integrated solution and designed to be used with the S HERLOCK® Tip
Location System (TLS) and SITE-RITE® Ultrasound System.
SITE-RITE® Ultrasound System, Needle Guide Kits, Probe Covers Create a feeding pathway directly into the stomach for people who Tubes provide ease of placement and removal. Low-Profile replacement devices Direct to Hospital Gastroenterologist
are unable to swallow and/or require nutritional support. provide convenience for ambulatory patients. Durable Medical Surgical
Equipment (DME) Endoscopist
Home Heath Care Interventional
providers Radiology
Nursing Homes Surgery
Pharmacy
Enteral Feeding Devices: Create a feeding pathway directly into the stomach for people who Tubes provide ease of placement and removal. Low-Profile replacement devices Direct to Hospital Gastroenterologist
PEG Tubes, Replacement G-Tubes, Low Profile Buttons, and J- are unable to swallow and/or require nutritional support. provide convenience for ambulatory patients. Durable Medical Surgical
Tubes Equipment (DME) Endoscopist
Home Heath Care Interventional
Providers Radiology
Nursing Homes Surgery
Pharmacy
Revised 03-07-11 Page 18 of 24
U.S. PRODUCT MATRIX
UROLOGY
BASIC DRAINAGE
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
UROLOGY PRODUCTS - BASIC DRAINAGE
Infection Control Foley Catheters and Trays: Procedural trays and kits for the continuous drainage and collection The BARDEX® I.C. anti-infective Foley catheter with Bacti-Guard®* silver alloy Primarily Distributors Infectious Disease
BARDEX® I.C. and LUBRI-SIL® I.C. Foley Catheters and Trays, of urine into a drainage bag or urine meter drainage bag. coating and BARD® hydrogel is clinically proven to reduce catheter-associated Physician
BARDEX® I.C. and LUBRI-SIL® I.C. COMPLETE CARE® Foley Catheter UTIs. BARDEX® I.C. COMPLETE CARE® Catheter System provides antimicrobial Infection Control
System with Bacti-Guard®* silver coating. agents built in to provide complete protection to reduce catheter-associated UTIs. Practitioner
Director of Nursing
The BARDEX® I.C. COMPLETE CARE® Foley Tray now features the STATLOCK® Foley Risk Manager
Stabilization Device. This device is designed to minimize movement, positioning, Urologist
traction and the risk of accidental dislodgement of the Foley catheter.
LUBRICATH® and LUBRI-SIL® Urine Meter Foley Trays Continuous bladder drainage and measurement of renal output. BARD® Hydrogel coating resists encrustation, and allows smooth, atraumatic Primarily Distributors Urologist
Procedural trays and kits for the continuous drainage and collection insertions and removal for enhanced patient comfort; wide breadth of line Director of Nursing
of urine into a drainage bag or urine meter drainage bag. (including complete assortment of latex-free products); Tamper-Evident seal Nurse Administrator
prevents disconnection of catheter drainage bag tubing junction; most Infection Control
comprehensive line in industry. Practitioner
Floor Nurse
Supervisor
Materials Mgt.
Director
Urinary Bags and Meters: Continuous or intermittent collection of urine for incontinent patients Anti-reflux valve; BARD® EZ-LOK® Sampling Port, easy-to-use accurate urine Primarily Distributors Director of Nursing
Urine Collection Drainage Bags and Urine Meter Drainage Bags and critical measurement for severely ill patients. meter, microbicidal outlet tube; broad line to meet specific customer needs. Nurse Administrator
Infection Control
All BARD® branded urine collection devices are 100% latex-free. Practitioner
Floor Nurse
Supervisor
Materials Mgt.
Director
Revised 03-07-11 Page 19 of 24
U.S. PRODUCT MATRIX
UROLOGY
BASIC DRAINAGE
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
UROLOGY PRODUCTS - BASIC DRAINAGE (Cont'd)
Extended Care: Discreet management of urinary incontinence; products designed The BARD® TOUCHLESS® Plus Intermittent catheter system is a closed system Director of Nursing
TOUCHLESS® Plus Intermittent Catheters, Urethral Catheters & specifically to meet the needs of the Extended Care Provider. designed to help reduce the risk of urinary tract infections. Rehab Nurses
Trays Extended Care
Distributors
Other Procedural Trays: Procedural trays and kits for therapeutic and diagnostic general Broad line to meet specific customer needs. Primarily Distributors Director of Nursing
Midstream Kits, Pediatric Urine Collectors care procedures. Nurse Administrator
Infection Control
Practitioner
Floor Nurse
Supervisor
Materials Mgt.
Director
Patient Monitoring: Critical Fluid Output and Core Bladder Temperature Monitor. Accurate, continuous and automatic temperature is achieved through a Foley Direct to Hospital Critical Care
BARD® CRITICORE® Monitor and Temperature-Sensing Foley catheter. Automated Urine measurement provides for faster assessment of the Physician
Catheters patient's conditions. Critical Care Nurse
Anesthesiologist
Perfusionist
Cardiovascular
Surgeon
Extended Care: Discreet management of urinary incontinence; products designed The BARD® TOUCHLESS® Plus Intermittent catheter system is a closed system Director of Nursing
BARDIA® Catheters and Trays specifically to meet the needs of the Extended Care Provider. designed to help reduce the risk of urinary tract infections. Rehab Nurses
Extended Care
Distributors
ENDOUROLOGY / STONE MGMT / PROSTATE MGMT / PERCUTANEOUS AND RENAL SURGERY
Ureteral Stents and Access Sheaths: Drainage of the kidney via stenting of the ureter. Provide protection Long-term indwelling time - Proprietary coating and ultra smooth surface help to Direct to Hospital Urologist
INLAY OPTIMA® Ureteral Stent, AQUAGUIDE® Ureteral Access of and continued access to the ureter. reduce calcium urine salt accumulation. The AQUAGUIDE® Ureteral Access Dealers
Sheath Sheath's dual lumen design allows multiple procedural applications such as
flushing out kidney stone fragments, additional irrigation for visibility and a second
channel for working equipment such as a safety wire.
Revised 03-07-11 Page 20 of 24
U.S. PRODUCT MATRIX
UROLOGY
STATLOCK® STABILIZATION DEVICES
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
STATLOCK® Stabilization Devices Stabilization for a broad spectrum of infusion therapy and drainage Only STATLOCK® Stabilization Devices 1) offer clinical proof of reducing catheter- Direct to Hospital and IV Nurse
catheters. related complications, 2) lead the market in the establishment of stabilization Distributors IC Nurse
standards of care, and 3) provide a fact-based economic model to support its cost- Direct to Hospitals, as Anesthesiologists
savings claims. well as through Kit (CVC, arterial)
Packers, OEM Material Managers
Partners, and Critical Care
Healthcare Department
Distributors. IV Nurses
CC & IC Nurses
Anesthesiologists &
Intensivists
Material Managers
RESPIRATORY - IC PRODUCTS
AGENTO® I.C. Silver-Coated Endotracheal Tube Ventilator associated pneumonia (VAP) preventative device for AGENTO® I.C. silver coated endotracheal tube (ET) is an anti-infective Primarily Distributors Pulmonologists
patients at risk of intubation for 24 hours or longer. endotracheal tube with a unique silver antimicrobial hydrophilic coating that has Intensivists
been clinically proven to reduce microbiologically confirmed VAP by 36% (p=0.03)
overall in patients intubated >24h , 48% within 10 days of intubation (p=0.005) and
significantly delays VAP onset (p=0.005).
Revised 03-07-11 Page 21 of 24
U.S. PRODUCT MATRIX
UROLOGY
INCONTINENCE
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
UROLOGY PRODUCTS - CONTINENCE
SURGICAL CONTINENCE AND PELVIC FLOOR RECONSTRUCTION
Sling / Urethral Support Therapies: Correction of stress urinary incontinence. High integrity synthetic mesh; self-anchoring, low profile delivery system; multiple Direct to Hospital Urologist
ALIGN® Urethral Support System, ALIGN® TO Trans-Obturator implant methods. PELVILACE® Support System: Natural porcine acellular collagen Direct to Physician Urogynecologist
Urethral Support System, PELVILACE® BioUrethral Support matrix sling. Minimizes risk of erosion that can occur with suture and bone anchor Gynecologist
System, PELVILACE® TO Trans-Obturator BioUrethral Support fixation. The only single-incision trans-oburator product on the market. Provides
System, AJUST® Adjustable Single-Incision Sling strong fixation in a clinically proven space with bi-directional adjustability.
Pelvic Floor Support Systems / Mesh: Correction of Pelvic Organ Prolapse. High integrity synthetic mesh, with or without long-term collagen barrier that acts Direct to Hospital Urologist
AVAULTA PLUS® BioSynthetic Support System, AVAULTA SOLO® as a mucosal protectant. SNARE™ introducer for improved depth of placement and Direct to Physician Urogynecologist
Synthetic Support System, AVAULTA® Anterior BioSynthetic ease of use. Gynecologist
Support System, AVAULTA® Posterior Synthetic Support System
Surgical Tissue: Correction of Pelvic Organ Prolapse and/or Correction of stress Just like PELVICOL® tissue, PELVISOFT® tissue is uniquely designed as an Direct to Hospital Urologist
PELVISOFT® Acellular Collagen BioMesh, PELVICOL® Acellular urinary incontinence. expandable all-natural biomesh optimizing in growth and revascularization. The Direct to Physician Urogynecologist
Collagen Matrix PELVICOL® implant is an all-natural, bio-compatible porcine collagen matrix that's Gynecologist
sterile, strong, and pliable. The PELVICOL® implant retains its structural integrity
over time and minimizes adhesions.
Bulking Therapy: Treatment for stress urinary incontinence. Minimally invasive incontinence therapy; hospital outpatient, ambulatory surgery Direct to Hospital Urologist
CONTIGEN® BARD® Collagen Implant center, office procedures. Direct to Physician Urogynecologist
Gynecologist
UROLOGY PRODUCTS - INCONTINENCE
Extended Care: Discreet management of urinary incontinence; products designed The BARD® TOUCHLESS® Plus Intermittent catheter system is a closed system Director of Nursing
Continence Products, Male External Catheters, Leg Bags specifically to meet the needs of the Extended Care Provider. designed to help reduce the risk of urinary tract infections. Rehab Nurses
Extended Care
Distributors
Revised 03-07-11 Page 22 of 24
U.S. PRODUCT MATRIX
UROLOGY
INCONTINENCE
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
UROLOGY PRODUCTS - INCONTINENCE (Cont'd)
DIGNICARE® Stool Management System Intended for fecal management by diverting and collecting liquid or The DIGNICARE® Stool Management System offers advanced features designed for Direct to Hospital ICU Staff
semi-liquid stool to minimize skin contact in bedridden patients. fecal containment. This may help to reduce risk of skin breakdown, minimize Nurse/Nurse Mgr.
exposure to infectious microorganisms, and save time and money associated with WOCN Nurse
bed linen changes and cleanups. ICP
ICU/Critical Care
Nurse Ed.
UROLOGY PRODUCTS - UROLOGICAL SPECIALTIES
CANCER / BRACHYTHERAPY
Brachytherapy Delivery System: Surgical intervention of CaP with radioactive seed implantation. The Total Brachytherapy Resource. Direct to Hospital Urologist
QUICKLINK® Brachytherapy Delivery System, READYLINK® QUICKLINK® Brachytherapy Delivery System builds custom seed Direct to Physician Radiation
Brachytherapy Delivery System, SOURCELINK® Brachytherapy trains quick, simple and safe. Oncologist
Delivery System, ISOSLEEVE® Seed Delivery System, QUICKLOAD™ Physicist
Manual Loader, SOURCELINK® Manual Loader, PROSEED® Service
Brachytherapy Equipment and Needles:
Brachytherapy Accessories, SURE-POINT® Stepper/Stabilizer Floor
Mount and Table Mount, Applicator Seed Needle, FASTFILL®
Needle, Seed Strand Implant Needle, Two Stage Seed Needle
ENDOUROLOGY / STONE MGMT / PROSTATE MGMT / PERCUTANEOUS AND RENAL SURGERY
Baskets: Kidney Stone Retrieval. Proprietary articulating feature that allows it to act like a basket as well as a Direct to Hospital Urologist
BARD® DIMENSION® Articulating Stone Basket/Grasper grasper. This allows controlled capture and release of stones. Dealers
Guidewires: Guidewire to gain access into ureter/kidney. Hydrophilic Nitinol guide wire with a multi-layered coating for durability. Direct to Hospital Urologist
NICORE® Nitinol Guidewire Dealers
U-NITE™ Hybrid Nitinol Wire Stiff Nitinol wire with a Hydrophilic tip and a PTFE shaft-uniting the features of an
access wire with a working wire.
Balloons: Provide balloon dilation to the ureter or percutaneous nephrostamy 30 ATM dilation force. Patented multilayer fiber technology for exceptional Direct to Hospital Urologist
X-FORCE® Balloon Dilation Catheter, X-FORCE® Nephrostomy tract. strength and unmatched durability. Dealers
Balloon Dilation Catheter
Revised 03-07-11 Page 23 of 24
U.S. PRODUCT MATRIX
SURGICAL
OTHER
BARD MEDICAL DIVISION Customer Service: 800-526-4455 Website: www.bardmedical.com
CLINICAL
BARD DIVISION/PRODUCTS USES SPECIAL FEATURES US DISTRIBUTION USER/DECISION
MAKERS
UROLOGY PRODUCTS - OTHER
Wound Management: Dressing for a variety of wound conditions including dermal ulcers, Provides the physiologic moist wound environment for optimum healing and Primarily Distributors Enterostomal
VIGILON® Wound Dressings pressure sores, and superficial wounds. promotes granulation tissue formation. Therapist
Radiation Oncology
Nurse
Skin Care: Skin care and protection for incontinent or incapacitated patients. Alcohol-free formulas, Vitamin E enriched formulas, comprehensive line. Primarily Distributors Enterostomal
SPECIAL CARE® Cream, NATURAL CARE® Gel, DOUBLE GUARD® Skin Therapist
Protectant Critical Care Nurse
Manager
Director of Nursing
Materials Mgt.
Director
Wound Drainage: Variety of wound drains and evacuators. The BARD® Channel drain improves drainage with less clotting, minimizes tissue Primarily Distributors Surgeon
BARD® Channel Drain, Wound Drains, Penrose Drains, invagination and reduces pain and trauma for the patient. O.R. Surgeon
Abramson Sump Drain, RELIAVAC® Evacuators and Other Materials Mgt.
Evacuators Director
Nasogastric Tubes: Stomach sumping. BARD® NG Tubes with the PREVENT® anti-reflux filters allow clinicians to see Primarily Distributors Materials Mgt.
BARD® NG Tubes with PREVENT® Anti-Reflux Filter gastric secretions in the lumen and alerts the clinician to take appropriate action. Anesthesiologist
Critical Care Nurse
ER Nurse
Other Procedural Trays: Procedural trays and kits for therapeutic and diagnostic general Broad line to meet specific customer needs. Primarily Distributors Director of Nursing
Urethral Catheter Trays, Irrigation Syringes and Trays care procedures. Nurse Administrator
Infection Control
Practitioner
Floor Nurse
Supervisor
Materials Mgt.
Director
* Bacti-Guard® silver alloy coating is licensed from Bactiguard AB. Bacti-Guard is a registered trademark of Bactiguard AB.
* S.A.F.E. = Secure Adhesive Free Tip Design.
Contigen is a registered trademark of Allergan, Inc. or its affiliate, licensed to C. R. Bard, Inc.
Gamma Finder is a registered trademark of World of Medicine
Lorad is a trademark of Hologic, Inc.
MicroPace and StimLab are trademarks or registered trademarks of Micropace
Sepramesh is a registered trademark of Genzyme Corporation, licensed to C. R. Bard, Inc.
Vectra is a registered trademark of Thoratec Corporation, licensed to C. R. Bard, Inc.
All other trademarks are the property of their respective owners
Revised 03-07-11 Page 24 of 24
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