The Zilver PTX was approved by the FDA in November 2012 after an FDA panel had recommended unanimously in favor. One of the pivotal clinical trials of the device compared the safety and effectiveness of the Zilver PTX stent to both balloon angioplasty (PTA) and bare metal stents (BMS). 479 patients with a single blockage less than 140 mm long in one or both femoropopliteal arteries were randomized to receive either the Zilver PTX or balloon angioplasty (PTA). If PTA failed, the patient received either a Zilver PTX or a bare metal stent.
At one year, 83% of narrowings treated with the Zilver were still open, compared with 33% in the balloon angioplasty control group. Among those patients who were then treated with stents, 90% of narrowings treated with the Zilver PTX were open at 12 months compared with 73% for those treated with the bare metal stent.
Cook Medical Distributes Zilver® PTX® Drug-Eluting Stent to Physicians in US, EU and Japan
August 7, 2013 -- Bloomington, Indiana -- Cook Medical is again shipping its Zilver® PTX® Drug-Eluting Peripheral Stent to medical centers in the U.S., Japan, Europe and other major markets. The shipments follow a brief period of unavailability due to a voluntary recall by Cook related to an issue with the stent's delivery catheter that has been resolved.
"This is great news for physicians treating peripheral artery disease in the superficial femoral artery because it means the only drug-eluting stent approved to treat this condition is available again in the U.S., Japan, Europe and other key markets," explained Rob Lyles, vice president and global leader of Cook's Peripheral Intervention clinical division. "Clinical trials have shown that compared to bare metal stents, Zilver PTX provides longer-lasting results and cuts the need for repeat procedures in half."
In 2009, Zilver PTX became the first drug-eluting peripheral stent in the world approved for peripheral artery disease (PAD) in the superficial femoral artery (SFA) when it was introduced to European physicians following CE Mark approval. The device, which received a unanimous recommendation for approval from the circulatory device review panel of the U.S. Food and Drug Administration, was approved U.S. sale in November 2012. In April 2012, it became the only drug-eluting peripheral stent approved for sale in Japan.
Tens of thousands of PAD patients in Europe, the U.S., Japan and more than 50 other markets around the world have been treated with the Zilver PTX stent. Cook's device features a self-expanding stent of shape memory nitinol coated with the anti-cell proliferation drug paclitaxel. In more than three years of clinical study compared to bare metal stents, Zilver PTX has been shown to have a proven drug effect, reduced reintervention rates, and longer-lasting vessel patency.
The Lancet reported last week that PAD has reached epidemic levels in the developed world, with 38 million new cases reported in the last 10 years.
"More than ever, doctors need the best tools possible to treat this disease," Lyles noted. "As the only company to produce drug eluting stent technology for PAD in the SFA, we're proud to help address that urgent need."
The device is being shipped, Lyles added, following regulatory approvals of the steps Cook has taken to address the issue of catheter tip separation that prompted Cook's voluntary recall.
About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world's healthcare systems deliver better outcomes more efficiently. We have always remained family-owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at www.cookmedical.com, and for the latest news, follow us on Twitter and LinkedIn.
