Peripheral Product Catalog - Medical Technology, …

1 1 PERIPHERALUSPRODUCT C ATA L O GJuly 2017 DIRECTIONAL ATHERECTOMY SYSTEMS HawkOne Directional Atherectomy System ---------------------------------------- ---------------------------------------- -----------4 TurboHawk Peripheral Plaque Excision System ---------------------------------------- ---------------------------------------- --------5 SilverHawk Peripheral Plaque Excision System ---------------------------------------- ---------------------------------------- ---------6 DRUG-COATED Admiral Paclitaxel-Coated PTA Balloon Catheter ---------------------------------------- -------------------------------------8 EMBOLIC PROTECTION SpiderFX Embolic Protection Device Ultra Proximal Cerebral Protection Device ---------------------------------------- ---------------------------------------- ----11 CTO DEVICESV iance Crossing Catheter ---------------------------------------- ---------------------------------------- ---------------------------13 Enteer Re-entry Catheter ---------------------------------------- ---------------------------------------- ---------------------------13 Enteer Guidewire ---------------------------------------- ---------------------------------------- -----------------------------------13 STENTSSELF-EXPANDING STENT SYSTEMSEverFlex Self-expanding Peripheral Stent with Entrust Delivery System ---------------------------------------- -----------------------15 EverFlex Self-expanding Peripheral Stent System ---------------------------------------- ---------------------------------------- -----16 Prot g EverFlex Self-expanding Biliary Stent System ---------------------------------------- ---------------------------------------1 7 Prot g GPS Self-expanding Peripheral and Biliary Stent System

2 ---------------------------------------- -----------------------------18 Prot g RX Self-expanding Carotid Stent SystemBALLOON EXPANDABLE STENT SYSTEMSVisi-Pro Balloon-expandable Peripheral Stent System ---------------------------------------- ---------------------------------------- 20 ParaMount Mini GPS Balloon-expandable Biliary Stent System ---------------------------------------- -------------------------------21 UNMOUNTED STENTSI ntraStent DoubleStrut LD Biliary Stent ---------------------------------------- ---------------------------------------- -------------22 IntraStent Mega LD Biliary Stent ---------------------------------------- ---------------------------------------- --------------------22 IntraStent Max LD Biliary Stent ---------------------------------------- ---------------------------------------- ---------------------22 PTA BALLOONSEverCross OTW PTA Balloon Catheter ---------------------------------------- ---------------------------------------- ----------------24 Admiral Xtreme PTA Balloon Catheter ---------------------------------------- ---------------------------------------- ---------------25 Fortrex " OTW HP PTA Balloon Catheter ---------------------------------------- ---------------------------------------- --------26 Pacific Plus PTA Catheter OTW " ---------------------------------------- ---------------------------------------- ----------------27 Pacific Xtreme PTA Balloon Catheter OTW " ---------------------------------------- ---------------------------------------- -----28 NanoCross Elite " OTW PTA Balloon Catheter ---------------------------------------- ---------------------------------------- ---29 RapidCross PTA Rapid Exchange Balloon Dilatation Catheter ---------------------------------------- ----------------------------------30 Chocolate * PTA Balloon

3 ---------------------------------------- ---------------------------------------- ------------------------------31 INFUSION THERAPYC ragg-McNamara Valved Infusion Catheters ---------------------------------------- ---------------------------------------- ---------33 ProStream Infusion Wires ---------------------------------------- ---------------------------------------- ----------------------------34 MicroMewi Infusion Catheters ---------------------------------------- ---------------------------------------- -----------------------34 SNARESA mplatz Goose Neck Snare Kit ---------------------------------------- ---------------------------------------- ----------------------36 Amplatz Goose Neck MicroSnare Kit ---------------------------------------- ---------------------------------------- -----------------36 Snare Replacement Catheters ---------------------------------------- ---------------------------------------- ------------------------37 GUIDEWIRESW holey Guidewire System ---------------------------------------- ---------------------------------------- ---------------------------39 Babywire Double-Ended Nitinol Guidewire ---------------------------------------- ---------------------------------------- -----------39 Nitrex Guidewire ---------------------------------------- ---------------------------------------- -----------------------------------40 SUPPORT CATHETERS.

4 Y-CONNECTORS & GUIDE CATHETERST railBlazer Support Catheter ---------------------------------------- ---------------------------------------- ------------------------42 TrailBlazer Angled Support Catheter ---------------------------------------- ---------------------------------------- -----------------42 BigEasy Rotating Y-Connector ---------------------------------------- ---------------------------------------- -----------------------43 Sequel Rotating Double Y-Connector ---------------------------------------- ---------------------------------------- ----------------43 Launcher Peripheral Guide Catheter ---------------------------------------- ---------------------------------------- -----------------43 BRIEF STATEMENTS & REFERENCE STATEMENTS ---------------------------------------- ---------------------------------------- -----44 TABLE OF CONTENTS3 DIRECTIONALATHERECTOMYHawkOne Directional Atherectomy System4 The HawkOne device is the latest addition to medtronic s directional atherectomy portfolio, which restores blood flow in PAD patients by removing plaque from blocked arteries.

5 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. HawkOne Directional Atherectomy SystemModel NameReferenceNumberVesselDiameter (mm)SheathCompatibility (F)CrossingProfile (mm)WorkingLength1 (cm)EffectiveLength2 (cm)TipLength (cm)Max. CutLength (mm)PackingDevice7 F HawkOne LS | Standard to FHawkOne LX | Extended to FHawkOne LS | Standard to FHawkOne LX | Extended to guidewire is for HawkOne HawkOne Working Length Distal end of pre-loaded flush tool, in the proximal position, to the distal end of tip. 2 HawkOne Effective Length Distal end of pre-loaded flush tool, in the proximal position, to the proximal end of cutter window. medtronic reserves the right to modify specifications without prior TurboHawk plaque excision system treats PAD by removing soft to moderately calcified plaque buildup in leg arteries.

6 This second generation device 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 guidewire is for all TurboHawk Sheath Compatibility - Per the Instructions For Use, the large vessel devices with smooth cutter are compatible with 8 F sheaths. A physician survey of device usage indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M device. Data on file with Length - distal end of strain relief to the distal end of Length - distal end of strain relief to the proximal end of cutter NameReferenceNumberVessel Diameter (mm)Sheath Compatibility1(F)CrossingProfile (mm)Working Length2 (cm)Effective Length3(cm)Tip Length (cm)Max Cut Length (mm) to to to to Peripheral Plaque Excision SystemMedtronic reserves the right to modify specifications without prior NameReference NumberVessel Diameter (mm)SheathCompatibility1(F)Crossing Profile (mm)Working Length2(cm)EffectiveLength3(cm)Tip Length (cm)Max CutLength(mm)Packing to to + to to to first-generation SilverHawk plaque excision system treats Peripheral arterial disease (PAD) by removing soft-to-mild plaque buildup in leg arteries.

7 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 guidewire is for all SilverHawk devices. 1 Sheath Compatibility - Per the Instructions For Use, the medium vessel and large vessel devices are compatible with 8 F sheaths. A physician survey of device usage indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M and MS-M (non-flush tip) devices. Data on file with Working Length - distal end of strain relief to the distal end of Effective Length - distal end of strain relief to the proximal end of cutter Peripheral Plaque Excision SystemMedtronic reserves the right to modify specifications without prior Admiral Drug-Coated Balloon Admiral Drug-Coated BalloonTECHNICAL SPECIFICATIONSP aclitaxel drug g/mm2 ExcipientUreaBalloon diameters4 mm - 7 mmBalloon lengths40, 60, 80, 120, 150 mm*Balloon fold mm: 3 Folds , and mm: 6 FoldsCatheter designOver the Wire (OTW)Catheter lengths80 cm and 130 cmGuidewire Nominal balloon pressure8 atmTECHNICAL SPECIFICATIONSM edtronic reserves the right to modify specifications without prior Admiral Drug-Coated Balloon (DCB) is a clinically proven, primary endovascular therapy that treats femoropopliteal disease, reduces interventions, and preserves future treatment options.

8 * NOTE: 120 mm and 150 mm lengths are not offered on the mm diameter balloon. Reference NumberUsable Length 80 cmReference NumberUsable Length 130 cmBalloon Diameter (mm)Balloon Length (mm)Recommended Introducer Sheath (F)Nominal Pressure (atm)RBP (atm)ADM 040 040 08 PADM 040 040 13P4405814 ADM 040 060 08 PADM 040 060 13P4605814 ADM 040 080 08 PADM 040 080 13P4805814 ADM 040 120 08 PADM 040 120 13P41205814 ADM 040 150 08 PADM 040 150 13P41505814 ADM 050 040 08 PADM 050 040 13P5406814 ADM 050 060 08 PADM 050 060 13P5606814 ADM 050 080 08 PADM 050 080 13P5806814 ADM 050 120 08 PADM 050 120 13P51206814 ADM 050 15 0 08 PADM 050 150 13P51506814 ADM 060 040 08 PADM 060 040 13P6406814 ADM 060 060 08 PADM 060 060 13P6606814 ADM 060 080 08 PADM 060 080 13P6806814 ADM 060 120 08 PADM 060 120 13P61206814 ADM 060 150 08 PADM 060 150 13P61506814 ADM 070 040 08 PADM 070 040 13P7407814 ADM 070 060 08 PADM 070 060 13P7607814 ADM 070 080 08 PADM 070 080 13P78078149 SpiderFX Embolic Protection UltraProximal Cerebral Protection Device10 Capture WireDelivery EndRecovery EndGuide Catheter/SheathReferenceNumberFilter Size (mm)Target Vessel Size (mm)Wire Length OTW/RX (cm)

9 Wire Diameter (in/mm)Crossing Profile (F)Diameter (F)Minimum ID (in) SVG & SVG & Carotid320 SVG & SVG & Carotid320 SVG & Lower SVG & Lower Extremity320 SVG & Lower SVG & Lower Extremity320 Lower Lower Extremity320 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 " or " guidewire, or through any " catheter* for ease of lesion crossing. 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 Embolic Protection DeviceMedtronic reserves the right to modify specifications without prior Ultra Proximal Cerebral Protection Device TECHNICAL SPECIFICATIONSB alloon materialCompliant elastomeric rubberBalloon marker distance6 cmRecommended ( mm)Balloon occlusion range5-13 mm diameter (CCA prox.)

10 Balloon) 3-6 mm diameter (ECA dist. balloon)Reference NumberMinimum Sheath Size (F)Inner Diameter of the Working Channel " reserves the right to modify specifications without prior SPECIFICATIONSUse the Ultra proximal cerebral protection device to contain and remove all sizes of debris that can dislodge during interventional procedures in the carotid arteries. The ultra device with double-occlusion balloon system allows for proximal embolic protection to be established prior to crossing a carotid TODEVICESE nteer Re-entry System Viance Crossing Catheter13 Reference NumberDescriptionWorking Length (cm)Guidewire Compatibility (in)Crossing Profile (max in)Sheath FReference NumberBalloon Size(W x H X L mm)Working Length (cm)Guidewire Compatibility (in)Crossing Profile (max in)Sheath CompatibilityENB-375-20-135AT x x 20135 FENB-275-20-150 BTK x x 20150 FReference NumberDescriptionDiameter(in)Length(cm)T ip Reach(mm) Viance catheter is designed to quickly and safely deliver a guidewire via the true lumen.