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PERIPHERAL U.S. PRODUCT CATALOG
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PERIPHERAL U.S. PRODUCT CATALOG - 1

PERIPHERAL U.S. PRODUCT CATALOG

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PERIPHERAL U.S. PRODUCT CATALOG - 2

TABLE OF CONTENTS DIRECTIONAL ATHERECTOMY SYSTEMS HawkOne™ Directional Atherectomy System-------------------------------------------------------------------------------------------- 4 TurboHawk™ Peripheral Plaque Excision System----------------------------------------------------------------------------------------- 4 SilverHawk™ Peripheral Plaque Excision System------------------------------------------------------------------------------------------ 5 DRUG-COATED BALLOON IN.PACT™Admiral™ Paclitaxel-Coated PTA Balloon...

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PERIPHERAL U.S. PRODUCT CATALOG - 3

DIRECTIONAL ATHERECTOMY SYSTEMS HawkOne™ Directional Atherectomy System

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PERIPHERAL U.S. PRODUCT CATALOG - 4

HawkOne™ Directional Atherectomy System The HawkOne™ device is the latest addition to the Medtronic directional atherectomy portfolio, which restores blood flow in PAD patients by removing plaque from blocked arteries. Just as the name implies, the HawkOne device is a comprehensive system that treats all morphologies, including severe calcium, and offers procedural efficiency with enhanced cutting, crossing, and cleaning capabilities. Vessel Sheath Reference Diameter Compatibility Crossing Profile Number (mm) (F) (mm) Working Effective Tip Length† Length** Length (cm) (cm) (cm) Max. Cut...

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PERIPHERAL U.S. PRODUCT CATALOG - 5

SilverHawk™ Peripheral Plaque Excision System The first-generation SilverHawk™ plaque excision system treats peripheral arterial disease (PAD) by removing soft-to-mild plaque buildup in leg arteries. SilverHawk system technology uses a directional cutting blade to shave plaque from the vessel — maximizing luminal gain. The plaque is captured in the nosecone and safely removed from the vessel. Product Name Reference Number Packing Device Max guidewire is 0.014” for all SilverHawk devices. Working length — distal end of strain relief to the distal end of tip. Effective length — distal end of...

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PERIPHERAL U.S. PRODUCT CATALOG - 6

DRUG-COATED BALLOON IN.PACT™ Admiral™ Drug-Coated Balloon Medtronic reserves the right to modify specifications without prior notice

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PERIPHERAL U.S. PRODUCT CATALOG - 7

IN.PACT™ Admiral™ Drug-coated Balloon The IN.PACT™ Admiral™ Drug-coated Balloon (DCB) is a globally leading DCB used for the treatment of femoropopliteal disease. Its drug formulation provides proven safety and sustained benefit while leaving future treatment options open. TECHNICAL S P E CI F I CAT I O N TEC HNI CALSPECIFICATIONS S TECH NICAL SP ECIFICATIONS Catheter design Excipient Balloon diameters Balloon lengths Balloon fold configuration Nominal balloon pressure Guidewire compatibility Catheter lengths Paclitaxel drug dose 120, 150, 200, and 250 mm lengths are not offered on the 7.0...

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PERIPHERAL U.S. PRODUCT CATALOG - 8

EMBOLIC PROTECTION SpiderFX™ Embolic Protection Device MO.MA Ultra™ Proximal Cerebral Protection Device

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PERIPHERAL U.S. PRODUCT CATALOG - 9

SpiderFX™ Embolic Protection Device The SpiderFX™ device is used to capture and remove debris that becomes dislodged during an interventional procedure. The SpiderFX device is the only embolic protection device that can be delivered over any 0.014" or 0.018" guidewire, or through any 0.035" catheter.† The SpiderFX device has the broadest indication among distal embolic filters. It is indicated for use in carotid arteries, coronary saphenous vein bypass grafts, and lower extremity procedures. Lower extremity procedures. Capture Wire Guide Catheter/ Sheath Reference Number Target Vessel Size...

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PERIPHERAL U.S. PRODUCT CATALOG - 10

Enteer™ Re-entry System Viance™ Crossing Catheter

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PERIPHERAL U.S. PRODUCT CATALOG - 11

Viance™ Crossing Catheter The Viance™ crossing catheter is designed to efficiently cross chronic total occulsions via the true lumen. The low-profile catheter, with its fast-spin torque handle, is designed to find small microchannels in a lesion, while leaving the control of crossing in the physician's hands. Reference Number Sheath Compatibility Enteer™ Re-entry System The Enteer™ system, consisting of the Enteer re-entry balloon catheter and the Enteer guidewire, provides the physician with control to reliably target the true lumen from the subintimal channel above or below the knee. The...

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PERIPHERAL U.S. PRODUCT CATALOG - 12

EverFlex™ Self-expanding Peripheral Stent System Visi-Pro™ Balloon-expandable Peripheral Stent System

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PERIPHERAL U.S. PRODUCT CATALOG - 13

EverFlex™Self-expanding Peripheral Stent with Entrust™Delivery System The Entrust™ delivery system is a one-handed stent delivery system with a low 5 F profile. This low profile was achieved without compromising the design of the EverFlex™ stent or the 0.035" guidewire compatibility. The device was engineered specifically for control and accuracy based on physician feedback during extensive interviews and procedural observations. The device is indicated for use in the superficial femoral artery. CATHETER LENGTH 80 cm Reference Number STENT SIZE 150 cm Reference Number Recomm. Introducer...

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PERIPHERAL U.S. PRODUCT CATALOG - 14

EverFlex™ Self-expanding Peripheral Stent System The EverFlex™ stent system is designed for flexibility and durability. It is a second-generation stent indicated for use in the superficial femoral and proximal popliteal arteries (SFA/PPA), common iliac, and/or external iliac arteries. The EverFlex stent is available in sizes ranging from 20 mm to 200 mm lengths (SFA/PPA) or 20-120 mm lengths (iliac). The broad size matrix, all deliverable through a 6 F catheter, provides the most appropriate single-stent fit. Peak-to-peak connection nodes disperse force uniformly, enhancing durability,...

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PERIPHERAL U.S. PRODUCT CATALOG - 15

Protégé™ EverFlex™ Self-expanding Biliary Stent System The Protégé™ EverFlex™ stent system is designed for the palliative treatment of malignant neoplasms in the biliary tree. The stent is made of nitinol and comes pre-mounted on an over-the-wire delivery system. The proximal and distal ends of the stent have tantalum radiopaque markers for enhanced visibility. Reference Number Unconstrained Stent Diameter (mm) Unconstrained Stent Length (mm) Each system includes one stent and delivery catheter system. Medtronic reserves the right to modify specifications without prior no

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