News | May 27, 2010

Study Reveals 86.2 Percent SFA Patency With Self-Expanding DES

May 27, 2010 – One-year data presented this week at EuroPCR in Paris confirms sustained clinical outcomes with Cook Medical's drug-eluting peripheral stent, Zilver PTX. According to data presented by professor Dierk Scheinert, medical director at Park Hospital Leipzig, 86.2 percent of all patient subgroups treated with Zilver PTX drug-eluting stent (DES) demonstrated vessel patency at 12 months without the requirement for an additional intervention.

The data were collected as part of the world's largest clinical study of endovascular treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA). The trial is based on a group of 787 patients, including symptomatic patients, diabetics, and those with the most complex lesions, including long lesions, total occlusions and in-stent restenosis.

The single-arm study also revealed:
• A low stent fracture rate of 1.5 percent
• On average a greater than 50 percent reduction in restenosis compared to published studies on bare-metal and other DES
• Improved clinical outcomes at 12 months according to all four key clinical indicators (ankle-brachial index, Rutherford Score, walking speed and walking distance)

"I think the patency data look great. A greater than 50 percent reduction of restenosis is quite impressive and surprising in a positive way," said Scheinert, a clinical investigator in the trial. "I'm looking forward to the final data from the randomized study, which could confirm this as a major step forward in treating severe lesions within the SFA."

Regulatory Clearance
Angiotech, the maker of the paclitaxel antiproliferative drug used on the Zilver stent, said the optimistic results of this trial will support Cook's application with the U.S. Food and Drug Administration (FDA). If cleared, it will become the first drug-coated peripheral stent available in the United States.
The Zilver PTX stent was CE marked in August 2009 and has been made available in Europe since September of 2009. It is the first drug-eluting stent indicated for treating PAD in the SFA in the leg.

Upon deployment, the Zilver PTX stent expands and holds open the artery to restore blood flow. It then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming. In a major advance over previous drug-eluting technologies, the Zilver PTX achieves targeted drug delivery without using a polymer to adhere the drug to the stent body. This eliminates the potential patient risks associated with polymer-coated devices, including clot formation and inflammation.

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