Cook Medical has received EU’s CE Mark to market the Zilver® PTX® paclitaxel eluting nitinol stent for the treatment of peripheral artery disease in the superficial femoral artery. The paclitaxel, a drug also used in the TAXUS cardiac stents by Boston Scientific, has been licensed from Angiotech. The interesting thing about the Zilver® PTX® is that the paclitaxel is attached to to the nitinol frame without the use of any polymer or other anchoring agent, which avoids leaving any plastics behind in the vessel once paclitaxel dissolves.
From Cook’s announcement of the approval:
The CE Mark follows the world’s largest-ever clinical trial for a peripheral stent, led by Dr. Michael Dake, professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and medical director of the Cath/Angio Laboratories at Stanford University Medical Center, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated highly positive results. Only 8 percent of all patients with de novo (new) lesions needed a reintervention to reopen the artery in the first 12 months — a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents.
Also, specific patient groups that are often very hard to treat, such as diabetics and patients with in-stent restenosis (those treated previously with a noncoated stent), were shown in the trial to benefit from the Zilver PTX. As the trial data indicate, the superior results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50 percent and 75 percent, an important patient benefit.
Cook press release: Breakthrough Drug-Eluting Stent to Treat Peripheral Artery Disease Now Available in Europe …
Angiotech press release: ANGIOTECH’S LICENSEE, COOK MEDICAL, ANNOUNCES CE MARK APPROVAL AND EUROPEAN LAUNCH OF THE ZILVER PTX STENT