Cook Medical Releases Nine-Month Data for ZILVER® PTX Drug-Eluting Stent Trial at International Symposium on Endovascular Therapy (ISET)

Cook Medical’s ZILVER PTX Paclitaxel-Eluting Stent (DES) trial results demonstrated no stent fractures. The major adverse event (MAE) rate was equivalent to conventional balloon angioplasty treatment at its six-month follow-up point, as reported by the trial’s national principal investigator.

Michael Dake, M.D., national principal investigator for Cook's ZILVER® PTX Drug-Eluting Stent Trial, presented important nine-month data on the first 60 patients in the randomized trial examining the safety of using Cook’s ZILVER PTX stent to treat blockages of the superficial femoral artery (SFA) above the knee.

Dake reported that the ZILVER Drug eluting stent showed an equal MAE rate to conventional angioplasty for treating SFA lesions. The ZILVER PTX stent also displayed a zero-percent fracture rate for 41 lesions at six months and 18 lesions at one year. Effectiveness of the device in treating lesions of the SFA will be shown in the pivotal trial, expected to start shortly in the United States, enrolling 420 patients at 50 sites.

"I'm very excited to be presenting this nine-month data from the ZILVER PTX trial," says Dake, professor and chairman of the department of radiology at the University of Virginia Health System.

“Drug-eluting technology combined with devices is the future of medical treatment. The results of this trial will be invaluable to the treatment of PAD in the future.”

This is the first trial ever to investigate whether Paclitaxel-eluting stents can be used to successfully treat peripheral arterial disease (PAD), a seriously under-diagnosed disorder affecting up to 20 percent of the adult population worldwide. Cook's ZILVER PTX drug-eluting vascular stent is an investigational device not approved for sale in the United States. It is under investigation for the use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery.

The data was compiled based on enrollment in the pilot portion of the clinical investigation, which began March 2005 and was completed last year. Enrollment in the pivotal trial (Phase II) is expected to begin in 2007. Additionally, a ZILVER PTX registry is ongoing worldwide, collecting data to support this technology.

The stent, a small metal device that acts like a scaffold, is used to prop open the blocked arteries following angioplasty. In many cases, arteries can become blocked again over time as scar tissue forms around the implanted stent. This blockage is called restenosis. To reduce or prevent restenosis, the ZILVER PTX stent is coated with Paclitaxel, a drug approved for clinical use as an anti-cancer agent. Paclitaxel coated coronary stents are approved for use in the United States to reduce the risk of restenosis of the coronary arteries. Cook is pioneering the development of drug-eluting stents (DES) to treat diseases outside the heart.

"The nine month data presented at ISET on the ZILVER PTX stent is certainly encouraging," explained Rob Lyles, global leader of Cook Medical's Peripheral interventional products division. "At Cook we believe the convergence of technologies, like devices and pharmaceuticals, holds great promise for treating PAD.

Physicians are seeking better options for their patients with PAD, and we believe that ZILVER PTX will prove to significantly improve clinical outcomes for patients."

Peripheral arterial disease (PAD) is similar to coronary artery disease in that fatty deposits build up in the arteries and block blood flow. PAD affects arteries outside the heart and brain, including arteries leading from the heart to the legs, arms, stomach or kidneys. PAD affects approximately ten million Americans each year; it can result in pain when walking and untreated can lead to gangrene and amputation.

For more information about the trial and the device, including details about clinical trial sites, visit either www.zilverptxtrial.com or at www.cookmedical.com.