TurboHawk. Plaque Excision System

Transcription

1 TurboHawk Plaque Excision System

2 Twelve-month Patency in Diabetics DIABETICS VS. NON-DIABETICS 12-month Primary Patency (%) Diabetic patients show a more positive response to directional atherectomy than to other therapies DEFINITIVE LE 1 77% 78% 1% 22% 71% 49% SABETTI 2 (BMS) Diabetic 53% 71% 18% Non-diabetic Diabetic DERUBERTIS 3 (PTA) Non-diabetic DEFINITIVE LE Clinical Study The landmark DEFINITIVE LE study is one of the largest multinational, multicenter PAD device studies to date, enrolling 800 patients from 47 sites in the U.S. and Europe. It provides insight into the clinical utility of directional atherectomy with the TurboHawk and SilverHawk devices in a broad range of patients (diabetics, nondiabetics, claudicants, and those with critical limb ischemia [CLI]). Key 12-month clinical findings from DEFINITIVE LE: Directional atherectomy is as effective in treating claudication in diabetics as in non-diabetics Treatment with directional atherectomy delivers 12-month patency of 78%, which is comparable to patency rates reported in stenting studies without leaving a foreign implant behind in the vessel and preserves future treatment options for patients Directional atherectomy is a viable option for treating PAD in no-stent zones where stents may be subjected to constant torsion and flexion Directional atherectomy achieves a limb salvage rate of 95% at 12 months in CLI patients Twelve-month Primary Patency Overall, primary patency results are comparable in diabetics vs. non-diabetics when treating short, medium, and long lesions primary patency at 12 months 100% 90% 80% 77% 70% 60% 50% 40% 30% 20% 10% 85% % 84% 71% 64% % < 4 cm cm 10 cm Diabetic Non-diabetic Mean Length

3 Maximize Lumen Gain, Maximize Results One Platform to Maximize Results The TurboHawk Plaque Excision System is Covidien s most advanced directional atherectomy platform to treat peripheral arterial disease (PAD). The new High Efficiency Cutter is now available to treat the toughest lesions above and below the knee. Treat PAD with technology that maximizes lumen gain, preserves a patient s native vessels, and keeps future treatment options open. Select a Cutter to Meet Procedural Needs High Efficiency (HE) Cutter Four contoured blades Engage and treat all plaque morphologies, including heavy calcium* Remove more disease with each pass, maximizing lumen gain Lesion Morphology HE Cutter All morphologies, including heavily calcified lesions* Smooth Cutter Mild- to moderately-calcified lesions Disease Removal Distal Flush Tool On-the-wire cleaning TurboHawk Model Name (Vessel Range) Large vessel: LS-C, LX-C 3.5 mm to 7.0 mm Small vessel: SX-C, SS-C, SS-CL 2.0 mm to 4.0 mm Large vessel: LS-M, LX-M 3.5 mm to 7.0 mm

4 Drive shaft Higher powered, counter-wound drive shaft Transmits power more efficiently to the contoured cutter blades Spin Percentage Comparison* TurboHawk catheter drive shaft 94% SilverHawk catheter drive shaft 50% N=20 Tapered tip Low profile, tapered tip Provides enhanced deliverability Small Vessel TurboHawk catheter Large Vessel TurboHawk catheter Maximize Procedural Efficiency Micro Efficient Compression (MEC ) Technology Tiny, laser-drilled nosecone holes Increase tissue collection capacity, potentially reducing procedure time and number of insertions MEC Technology Tissue Capture* 103 mg MEC Catheter 71 mg Non-MEC Catheter N=7 MEC Technology 32 % increase in the catheter s tissue collection capacity with MEC technology

5 Dual catheter jog Versatile, dual catheter jog Cutter Apposition Comparison* Ensures consistent cutter contact in a wide range of vessels Reduces the need for multiple catheter use Apposition Force (lb) Same apposition force as the SilverHawk device in smaller vessels Improved apposition force in larger vessels TurboHawk device SilverHawk device Vessel Diameter (mm) N=34 Cleaning Effectiveness* Test Units Cleaned on First Flush (%) HE Cutter 20% Super Cutter 80% N=5 400 % improvement in cleaning Catheter Alignment marker Provides easy alignment of the nosecone in the flush tool for faster cleaning New Distal Flush Tool Offers increased pressure during cleaning for effective flushing

6 TURBOHAWK Plaque excision system PLATFORM Directional Atherectomy Peripheral Catheters LARGE VESSEL Model Name LS-C High Efficiency Cutter Large Vessel Standard Calcium Tip LX-C High Efficiency Cutter Large Vessel Xtended Calcium Tip LS-M Smooth Cutter Large Vessel Standard Tip Catalog Number Vessel Diameter (mm) Sheath Compatibility (F) Crossing Profile (mm) Working Length 1 Effective Length 2 Tip Length Max. Cut Length (mm) THS-LS-C 3.5 to THS-LX-C 3.5 to TH-LS-M 3.5 to / Packing Device TurboHawk Models LS-C, LX-C, LS-M, LX-M Common Femoral 5 mm 8 mm Superficial Femoral (SFA) 4 mm 7 mm LX-M Smooth Cutter Large Vessel Xtended Tip TH-LX-M 3.5 to / SMALL VESSEL SX-C High Efficiency Cutter Small Vessel Xtended Calcium Tip SS-C High Efficiency Cutter Small Vessel Standard Calcium Tip SS-CL High Efficiency Cutter Small Vessel Standard Calcium Tip Long Catheter SilverHawk DS Distal Vessel Standard Tip THS-SX-C 2.0 to THS-SS-C 2.0 to THS-SS- CL 1 Working Length - distal end of strain relief to the distal end of tip. 2 Effective Length - distal end of strain relief to the proximal end of cutter window. 2.0 to P to SX-C, SS-C, SS-CL DS Popliteal 3 mm 6 mm Tibial Peroneal Trunk 3 mm 4 mm Anterior Tibial 2 mm 4 mm Peroneal 2 mm 3 mm Posterior Tibial 2 mm 3 mm Dorsalis Pedis 1.5mm 2 mm REFERENCES 1. Garcia L. DEFINITIVE LE Determination of EFfectiveness of the SilverHawk PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities 12-month Final Results. VIVA Sabeti S, Mlekusch W, Amighi J, et al. Primary Patency of Long-segment Self-expanding Nitinol Stents in the Femoropopliteal Arteries. J Endovasc Ther. Feb 2005; 12(1): DeRubertis BG, Pierce M, Ryer EJ, et al. Reduced Primary Patency Rate in Diabetic Patients after Percutaneous Intervention Results from More Frequent Presentation with Limb-threatening Ischemia. J Vasc Surg. Jan 2008; 47(1): DEFINITIVE LE stands for Determination of EFfectiveness of the SilverHawk PerIpheral Plaque ExcisioN System (SIlverHawk) for the Treatment of Infrainguinal VEssels / Lower Extremities. Find out more about TurboHawk innovations, systems, and clinical results at *Large vessel catheters: When used in hard, complex calcified lesions the TurboHawk catheter should be paired with the SpiderFX Embolic Protection Device to mitigate the risk of distal embolization. Small vessel catheters: Do not use in hard, complex calcified lesions due to the risk of distal embolization that may result from excising this type of lesion. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. COVIDIEN, COVIDIEN with logo, Covidien logo, and positive results for life are trademarks of Covidien AG. TurboHawk and SilverHawk are trademarks of a Covidien Company Covidien (A) SEP/12 Peripheral Vascular 3033 Campus Drive, n550 Plymouth, MN ph fx cs