Cook Medical's Zilver PTX Shows Favorable 4-Year Revascularization Rate

September 16, 2013—Cook Medical (Bloomington, IN) announced that 83.2% of patients with femoropopliteal lesions who were treated with the company's Zilver PTX self-expanding paclitaxel-coated nitinol stent did not require revascularization at 4 years. This freedom from target lesion revascularization (TLR) rate compares favorably to the 69.4% freedom from TLR rate at 4 years in patients treated with percutaneous transluminal angioplasty (PTA) and a bare metal stent.

The Zilver PTX trial is a multicenter, prospective, randomized study that is designed to evaluate the stent as a treatment for peripheral arterial disease in the superficial femoral artery (SFA).

The Zilver PTX study's Global Principal Investigator, Michael Dake, MD, presented the 4-year freedom from TLR trial data at CIRSE 2013, the annual congress of the Cardiovascular and Interventional Radiological Society in Barcelona, Spain.

Dr. Dake, who is Professor of Cardiothoracic Surgery at Stanford University Medical School, commented in the company's press release, “The 4-year freedom from TLR data documents the sustained clinical benefit of Zilver PTX. When compared to standard-of-care therapy, consisting of either successful PTA or provisional bare stent placement after suboptimal PTA, the paclitaxel-eluting Zilver stent provides a 45% reduction in the reintervention rate.”

The company noted that after Dr. Dake's presentation at CIRSE, a number of European experts also shared their experiences with the stent and discussed why and when physicians should use drug-eluting devices to treat lesions in the SFA. Zilver PTX received US Food and Drug Administration approval in 2012 and European CE Mark approval in 2009.