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Peripheral Intervention
November 28th, 2016

New Zilver® PTX® thumbwheel stent delivery system receives FDA approval


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The FDA has approved a new rotating thumbwheel delivery system for Cook Medical’s Zilver® PTX® drug-eluting peripheral stent. The new system, now available for sale throughout the United States, Canada, Europe, and Japan, provides simplified deployment of the world’s first drug-eluting stent for the superficial femoral artery (SFA).

Engineers in Peripheral Intervention (PI) were tasked with improving the precision and deliverability on the previous pin-and-pull system. The thumbwheel design features include an ergonomic handle that facilitates single-handed deployment. The new system has surpassed many of the expectations for several of the new features.

In addition to the new deployment system, 120 mm length Zilver PTX stents and a smaller box design are also now available in the United States.

Watch Dr. Andrew Holden, director of Interventional Services at Auckland City Hospital and associate professor of Radiology at Auckland University School of Medicine in New Zealand, perform the first-in-man case using the new thumbwheel.

Dr. Holden is a paid consultant for Cook Medical.

Zilver® PTX® Drug-Eluting Peripheral Stent
ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INDICATIONS: Indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.

CONTRAINDICATIONS: Women who are pregnant, breastfeeding, or plan to become pregnant in the next 5 years should not receive a Zilver PTX Drug-Eluting Peripheral Stent. It is unknown whether paclitaxel will be excreted in human milk, and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. • Patients who cannot receive recommended anti-platelet and/or anti-coagulant therapy. • Patients judged to have a lesion that prevents proper placement of the stent or stent delivery system.

WARNINGS: Persons with allergic reactions to nitinol, or its components, nickel and titanium, may suffer an allergic reaction to this implant. • Persons allergic to paclitaxel or structurally-related compounds may suffer an allergic reaction to this implant. • The inner package should not be opened or damaged prior to use to maintain sterility; do not use if inner package is opened or damaged. • The use of this Drug-Eluting Peripheral Stent carries the risks associated with peripheral artery stenting, including vascular complications, and/or bleeding events. • The safety and effectiveness of implanting multiple Zilver PTX Drug-Eluting Peripheral Stents with a total drug coating quantity of greater than 3 mg paclitaxel (i.e., an additive stent length greater than 160mm per limb) has not been established.

POTENTIAL ADVERSE EVENTS: Potential adverse events that may occur include, but are not limited to, the following: Allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium • Allergic reaction to nitinol • Atheroembolization (Blue Toe Syndrome) • Arterial aneurysm • Arterial rupture • Arterial thrombosis • Arteriovenous fistula • Death • Embolism • Hematoma/hemorrhage • Hypersensitivity reactions • Infection • Infection/abscess formation at access site • Ischemia requiring intervention (bypass or amputation of toe, foot, or leg) • Pseudoaneurysm formation • Renal failure • Restenosis of the stented artery • Stent embolization • Stent malapposition • Stent migration • Stent strut fracture • Vessel perforation or rupture • Worsened claudication/rest pain • Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating: Allergic/immunologic reaction to the drug coating • Alopecia • Anemia • Blood product transfusion • Gastrointestinal symptoms • Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) • Hepatic enzyme changes • Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis • Myalgia/Arthralgia • Myelosuppression • Peripheral neuropathy

See package insert for full product information.

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