Cook Medical cook trial 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. Previous concerns about the early thrombosis of drug eluting coronary stent tempered enthusiasm somewhat however it appears that the ploymer used to attach the drugs was the culprit as opposed to the stent itself. The Proprietary technology from cook appears to have addressed the issue.
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 Medical has been an innovator in utilizing new media to enhance clincial outcomes. (See The Landing Zone)Cook also has initiated a first-of-its-kind open clinical database on SFA treatments. The SFA Open-Registry provides physicians with an opportunity to exchange ongoing, real world treatment results. Utilizing an intuitive web interface, clinicians may track their patients, view the medical community's trends in treating PAD 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 participating physicians.
Another key breakthrough is Cook's commitment to a patient-focused strategy that should make the device available to virtually any PAD patient who needs it, Lyles explained. As part of its ongoing corporate mission to help reduce global health care delivery costs, Cook has adopted a unique 'affordable innovation' strategy aimed at reducing any potential financial or reimbursement barriers to its widespread adoption as the standard of care for PAD in the SFA.
Cook licenses the rights to use paclitaxel on peripheral stents and other noncoronary medical devices from Angiotech Pharmaceuticals, Inc., of Vancouver, British Columbia, Canada (http://www.angiotech.com, NASDAQ: ANPI, TSX: ANP). In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.
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