Eighteen patients in Europe on Monday received the first CE mark approved drug-eluting stent (DES) designed specifically to treat severe blockages in the challenging and largest artery in the leg, according to Cook Medical (Bloomington, Indiana). The device — the polymer-free Zilver PTX drug-eluting peripheral stent — opens up a treatment option to patients in Europe that didn't exist before this week.

"That's 18 people that last week didn't have access to it," Rob Lyles, global leader and VP of Cook's Peripheral Intervention division, told Medical Device Daily. "That's a good day."

According to Cook, the CE mark of the Zilver PTX represents a "global landmark in effective peripheral intervention for treating peripheral artery disease (PAD), a chronic disease affecting tens of millions of patients worldwide that is a leading cause of leg amputation and shortened lifespans."

"It is a very exciting day for Cook," Lyles said. "More importantly, I think, it's a really great day for patients. At the end of the day that's what its always about ... this is a really significant step forward for patients."

Prior to Cook's Zilver PTX receiving CE mark, PAD patients in Europe had three treatment options, Lyles said: surgery, balloon angioplasty, or a bare metal stent.

The first option, surgery, is accompanied by the pain of undergoing surgery, a hospital stay of at least a few days followed by recovery time, risk of infection, and probably two to three weeks off of work, Lyles said.

Second, he said, if a patient with PAD in Europe finds a doctor who will do a minimally invasive procedure, 40% of the time that physician is going to do a balloon angioplasty. That statistic "blows me away," Lyles told MDD, because that procedure fails 70% of the time and the patient has to go back for a repeat procedure, usually two years later. "That means that 40% of the time they are going to get a technology that we know is going to fail them."

The third treatment option available prior to this CE mark, treatment with a bare metal stent, is better than the first two options, however the success rate is still only 75% to 80%, compared to the Zilver PTX data which is showing success 92% of the time.

"They suddenly, in Europe, have an option that they've never had before," Lyles said.

Cook's Zilver PTX is specifically designed and approved to treat PAD affecting the main blood vessel in the thigh, the superficial femoral artery (SFA). It is a self-expanding stent made of nitinol, a space-age shape memory' metal that offers unique mechanical advantages for a stent in the SFA.

"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," Lyles said. "It's polymer-free, it's 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."

By eliminating the need for a polymer or plasticizing agent to hold the drug to the stent body, Cook says it has created a "medical breakthrough" that solves two key problems. First, it allows targeted delivery of a drug (paclitaxel) proven to reduce the renarrowing (restenosis) of arteries opened using balloon angioplasty. Second, by eliminating the need for a polymer, which was left behind on the body of earlier drug-eluting stents after the drug dissolved into the surrounding tissues, Zilver PTX avoids the potential patient risks posed by leaving a permanent foreign, plastic substance in the body. In addition, the Zilver stent was proven during its clinical trial to be the most durable peripheral stent available, suggesting even greater patient safety, according to the clinical trial data.

"Our unique ability to adhere the drug to the stent without using a polymer is a major clinical advantage," Lyles said. "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."

According to Cook, the CE mark follows the world's largest-ever clinical trial for a peripheral stent, led by Michael Dake, MD, 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 data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated "highly positive results," Cook noted. Only 8% of all patients with de novo (new) lesions needed a reintervention to reopen the artery in the first 12 months — a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal stents, the company said.

Also, specific patient groups that are often very hard to treat, such as diabetics and patients with in-stent restenosis (those treated previously with a non-coated stent), were shown in the trial to benefit from the Zilver PTX. As the trial data indicate, the superior results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone, Cook said. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50% and 75%, an important patient benefit.

"The awarding of the CE mark is set to herald a revolution in the treatment of peripheral arterial disease," Dake said. "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."

Following more than 1,200 patients treated worldwide during its clinical evaluation and CE mark approval on July 24 the first commercial implantations of the Zilver PTX stent were conducted Monday in a coordinated effort by physicians in the UK, Germany, France, the Netherlands, Belgium, Sweden, Switzerland and Spain. In the U.S., the Zilver PTX DES is an investigational device not available for sale. Lyles told MDD that Cook is looking to bring the device to the U.S. market in the next 18 months, but of course that is purely speculation, he said.

Cook licenses the rights to use paclitaxel on peripheral stents and other non-coronary medical devices from Angiotech Pharmaceuticals (Vancouver, British Columbia).

"Cook is to be congratulated for succeeding where many others have failed in making drug-eluting stent technology a reality for patients with peripheral vascular disease," said Bill Hunter, PhD, president/CEO of Angiotech. "The Zilver stent platform has shown tremendous durability and performance in clinical trials, and when combined with the proven benefits of paclitaxel in the prevention of restenosis, the Zilver PTX is poised to become the first choice for interventionalists in the management of this common medical condition."

From a corporate standpoint, Lyles said Cook is "very enthused" about the CE mark, and that it thinks the Zilver PTX stent has the potential to "really drive a tremendous amount of market share."

"There is just nothing else out there from our competitors that's even close," Lyles said.

Amanda Pedersen, 229-471-4212; amanda.pedersen@ahcmedia.com