Against the backdrop of the disappointing STRIDES trial data, COOK Medical launched the first drug-eluting stent for use in the superficial femoral artery in Europe.
Michael Dake presented highly promising registry data out to two years, but this did not include patency as an endpoint which will be available once the results of the US randomised trial are presented next year. The Zilver PTX registry is the the largest registry of its kind ever conducted and results indicate that the Zilver PTX stent can effectively bridge the gap between the patient results achieved using open surgical bypass graft procedure.
“With the Zilver PTX stent, Cook has introduced a true landmark device that can reduce the number of PAD patients having to endure the trauma of leg amputations and bypass surgeries,” explained Rob Lyles, vice president and global leader of Cook Medical’s peripheral intervention unit. “Clinically proven, polymer-free and exceptionally durable, we expect the Zilver PTX stent to become the new standard of care for PAD in the SFA.”
Zilver PTX was introduced commercially to European physicians at the annual CIRSE meeting, held this year from 19-23 September in Lisbon. The launch included several important developments, including the introduction of a new website, http://www.cookmedical.com/zilverptx, with clinical and practical information on the device for patients and physicians in English and major European language languages, and a twitter page for live updates from CIRSE, http://www.twitter.com/ZilverPTX.
Cook also has initiated a first-of-its-kind open clinical database on SFA treatments. The SFA “Open Door” Registry provides physicians with an opportunity to exchange ongoing, real world treatment results. Utilising an intuitive web interface, clinicians may track their patients, view the medical community’s trends in treating peripheral arterial disease and determine the most effective treatment options. Transparency will be a central objective of the SFA Open-Registry, with results for all treatment types available to researchers, regulatory bodies and the public.
In an interview with Interventional News, Rob Lyles indicated that Cook had adopted a unique ‘affordable innovation’ strategy to overcome potential financial or reimbursement barriers in Europe.
Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals of Vancouver, British Columbia, Canada. In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.