The physicians at UK completed patient implants of the stent designed specifically to treat severe blockages in the complicated and largest artery in the leg.
Cook Medical announced the availability of its first European CE marked Zilver PTX Stent.
The polymer-free Zilver PTX Drug-Eluting Peripheral Stent from Cook medical is effective for peripheral intervention for treating peripheral artery disease (PAD) affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). This self-expanding stent is made of nitinol that provides unique mechanical advantages for a stent in the SFA.
This polymer or plasticising agent free stent allows targeted delivery of a drug (paclitaxel) using balloon angioplasty. Unlike the polymer, which was left behind on the body of earlier drug-eluting stents after the drug dissolved into the surrounding tissues, Zilver PTX eliminates the patient risks caused due to left out permanent foreign, plastic substance in the body. In addition, Zilver PTX was proved for its durability and patient safety in clinical trials.
The CE Mark was obtained after the clinical trial which was led by Dr. Michael Dake, professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and medical director of the Cath/Angio Laboratories at Stanford University Medical Center, Palo Alto, California. The trial involved 791 patients from Europe, Russia, Canada, and Korea and produced highly positive results. Of all, only 8% of patients with de novo (new) lesions required a reintervention to reopen the artery in the first 12 months, a rate significantly surpassing present treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents.
Zilver PTX could also effectively treat challenging patients such as diabetics and patients with in-stent restenosis (those treated previously with a noncoated stent). The results from the first year were maintained throughout 24 months. The Zilver PTX stent showed a reduction in re-intervention of between 50% and 75%, when compared to other trials.
“The awarding of the CE Mark is set to herald a revolution in the treatment of peripheral arterial disease,” comments Dr. Michael Dake. “This global study proves that the Zilver PTX has the integrity, safety, and durability needed to successfully address many of the well-known limitations of current treatments for the management of PAD.”
Rob Lyles, global leader and vice president of Cook Medical’s Peripheral Intervention division states, “We’ve specifically designed the Zilver PTX to be safer and more effective for PAD patients by engineering this device for the unique demands of treating this disease in the SFA. It’s polymer free, fracture resistant and through the largest trial of its nature in history, it’s been clinically proven to be significantly more effective in treating peripheral arterial disease in the SFA than other treatment modalities.
Our unique ability to adhere the drug to the stent without using a polymer is a major clinical advantage. It eliminates the risk some patients may face due to reactions and other potentially poor outcomes that are associated with polymer coatings used on current generations of drug-eluting stents. It’s a truly exciting time for Cook Medical and our partners, as well as for physicians and patients alike. With the European launch of this first-of-its-kind 21st century medical technology, we are truly at the vanguard of a revolution in peripheral intervention.
After treating 1,200 patients worldwide during its clinical evaluation and CE Mark approval on 24 July 2009, Cook Medical launced Zilver PTX stent in the United Kingdom, Germany, France, Holland, Belgium, Sweden, Switzerland and Spain. The Zilver PTX drug-eluting stent is an investigational device not available for sale in US.
Dr. Nick Chalmers from the Manchester Royal Infirmary in UK participated in the first commercial use.