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Peripheral Intervention
September 16th, 2016

Zilver® PTX® recognized as U.S. SFA stent market-share leader

Zilver PTXZilver PTX is now treating more patients than ever before. According to Decision Resources Group’s Peripheral Vascular Devices | US | 2016 | Market Analysis report, Zilver PTX has captured market-share leadership for revenue-based sales among all competitive stents used to treat the superficial femoral artery (SFA).

DRG’s research shows that Zilver PTX went from seventh place (4.2%) to first place (23.7%) over the last three years in the femoropopliteal category.

“This is wonderful news for U.S. patients suffering from peripheral arterial disease,” said Mark Breedlove, vice president and global leader for Cook Medical’s Peripheral Interventional (PI) division. “More patients are being treated with Zilver PTX, which is the only endovascular device for the SFA that has five-year randomized controlled trial data.

“Considering the fact that Zilver PTX is the only drug-eluting SFA stent with 5-year data, we expect the adoption of Zilver PTX will continue to grow as physicians take note of the long-term patency and freedom from TLR in their own patients,” Breedlove added.

Data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease showed 5-year primary patency of 72% in the SFA for patients treated with Cook’s paclitaxel-eluting stent. This compares to 53% percent patency for patients who received provisional Zilver bare-metal stent placement.

The Zilver PTX Randomized Trial of Paclitaxel-Eluting Stents for Femoropoliteal Artery Disease was a 479-patient multicenter, prospective, randomized study, designed to evaluate the stent as a treatment for peripheral arterial disease (PAD) in the SFA.

© 2013 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.
© 2015 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.

Zilver® PTX® Drug-Eluting Peripheral Stent

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.