Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee

GAITHERSBURG, Md.--()--The Zilver® PTX® Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee, Cook Medical announced today. The panel convened today in the Washington, DC area and all 11 of its members voted to recommend approval of the device on the basis of its safety, efficacy and acceptable risk profile. The recommendation is the latest step in the regulatory review process that the company hopes will ultimately lead to FDA approval to sell the Zilver PTX stent in the U.S.

“Cook Medical is very pleased that the FDA’s Circulatory System Devices Panel has recognized the merits of Zilver PTX, and we look forward to a final decision on approval to market this device in the U.S. from the FDA in the coming months,” said Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “Cook Medical is dedicated to continually innovating and delivering medical devices that improve the quality of patient care worldwide, and we wholeheartedly feel Zilver PTX provides a great example of that patient-focused business philosophy.”

Following CE Mark approval in 2009, Cook Medical’s Zilver PTX Drug Eluting Stent is now available for sale in 48 countries around the world including the United Kingdom, Germany, France, Brazil, New Zealand and Taiwan, Lyles added.

About Cook Medical

Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit CookMedical.com. Follow Cook Medical on Twitter @CookMedicalPR.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50029178&lang=en

Contacts

Cook Medical
David McCarty, 812-339-2235 ext. 2387
Director, Global Public Relations
Mobile: 812-322-1805
Dave.McCarty@CookMedical.com
or
Racepoint Group
Cheri Keith, 781-487-4672
Mobile: 781-258-6727
ckeith@racepointgroup.com

Zilver(R) PTX(R) is a self-expanding, drug-eluting stent specifically designed to treat peripheral vascular disease affecting the superficial femoral artery (SFA), an often difficult-to-treat vessel. Zilver PTX is a combination therapy device that both restores patency and provides targeted delivery of paclitaxel, an antiproliferative drug proven to reduce arterial restenosis. This drug coats the stent without the use of a polymer, thereby eliminating the risk associated with polymers. Zilver PTX is made of nitinol, a "shape memory" metal alloy, and is engineered to withstand the dynamic forces of the SFA with optimized axial, torsional and bending flexibility. (Graphic: Business Wire)

Zilver(R) PTX(R) is a self-expanding, drug-eluting stent specifically designed to treat peripheral vascular disease affecting the superficial femoral artery (SFA), an often difficult-to-treat vessel. Zilver PTX is a combination therapy device that both restores patency and provides targeted delivery of paclitaxel, an antiproliferative drug proven to reduce arterial restenosis. This drug coats the stent without the use of a polymer, thereby eliminating the risk associated with polymers. Zilver PTX is made of nitinol, a "shape memory" metal alloy, and is engineered to withstand the dynamic forces of the SFA with optimized axial, torsional and bending flexibility. (Graphic: Business Wire)

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Release Summary

The Zilver® PTX® Drug-Eluting Stent has received a unanimous recommendation from the Food and Drug Administration’s (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee.

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Contacts

Cook Medical
David McCarty, 812-339-2235 ext. 2387
Director, Global Public Relations
Mobile: 812-322-1805
Dave.McCarty@CookMedical.com
or
Racepoint Group
Cheri Keith, 781-487-4672
Mobile: 781-258-6727
ckeith@racepointgroup.com