First Renal Artery Disease Patient Enrolled in Trial of Cook Medical's Formula PTX DES

April 12, 2010—Cook Medical (Bloomington, IN) has enrolled the first patient in a clinical trial that will evaluate the safety and effectiveness of the company’s Formula PTX paclitaxel-eluting, polymer-free stent to treat renal artery disease. The multicenter, randomized trial is expected to enroll 120 patients at sites across Europe. Initial results are expected in the fourth quarter of 2010.

According to the company, the trial utilizes Cook’s Formula renal stent, which is designed with a very low profile that may help it cross tightly blocked vessels for placement in diseased renal arteries. The stent is a slotted tube constructed of a medical-grade stainless steel that is mounted onto a balloon catheter specifically designed for the stent. Once placed at the site of the blockage, the balloon is inflated, expanding the stent and opening the vessel. The balloon is then deflated and withdrawn, leaving the stent behind to act like a metal scaffold to hold open the vessel and restore blood flow.

Professor Dierk Scheinert, MD, of Park-Krankenhaus Leipzig-South in Germany, which is a participating center in the trial, commented, “After Cook Medical’s success with the Zilver PTX paclitaxel-eluting stent (to treat peripheral artery disease in the superficial femoral artery), we chose to be involved in the clinical trial for the Formula PTX balloon expandable renal stent. Given the early success of the US REFORM clinical trial evaluating the Formula balloon-expandable stent, we remain very excited about the potential of a drug-eluting renal stent. Providing physicians with a greater range of devices will ultimately help patients receive the best possible treatment options.”

The Zilver PTX drug-eluting stent and the Formula PTX balloon-expandable stent are not approved by the US Food and Drug Administration for sale in the United States, the company advised.