Patients suffering from blockages of the renal arteries, a condition often leading to high blood pressure and kidney failure, may one day enjoy the clinical benefits of the latest drug-eluting stent technology if a new clinical trial proves the safety and efficacy of a new generation of these devices.
Cook Medical has enrolled the first patient in its landmark Formula PTX clinical trial. The trial is the first of its kind to evaluate the safety and effectiveness of a paclitaxel-eluting, polymer-free stent to treat renal artery disease, the narrowing of the arteries that supply blood to the kidneys. The multi-centre, randomised trial plans to enrol 120 patients at sites across Europe and initial results are expected in Q4 of 2010.
The trial utilises Cook’s Formula renal stent, which is designed with a very low profile that may help it cross tightly blocked vessels for placement into 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 The balloon is then deflated and withdrawn, leaving the stent behind to act like a metal scaffold to hold open the vessel and restore blood flow.
The choice of paclitaxel for the Formula PTX Balloon Expandable Renal Stent follows the proven results of the world’s largest clinical trial of its kind for Cook Medical’s Zilver PTX drug-eluting peripheral stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA). The CE marked Zilver PTX is clinically proven, polymer-free and exceptionally durable, delivering paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming.
“The proven clinical results of the Zilver PTX have shown the success of polymer-free paclitaxel elution in treating blockages in the peripheral arteries. Applying this technology to other devices, like the Formula balloon expandable renal stent, has the potential to significantly help patients in the battle against renal artery stenosis,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention business unit. “Cook Medical is committed to enhancing the delivery of care to patients and we are looking forward to the initial results from the trial later this year.”
Professor Dierk Scheinert, Angiology and Cardiology Specialist at participating hospital, Park-Krankenhaus Leipzig-South, said: “Following Cook Medical’s success with the Zilver PTX, 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.”