|ANPI's paclitaxel technology gets CE Mark approval|
|By Staff and Wire Reports|
|Tuesday, 11 August 2009 08:38|
"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 Dr. Bill Hunter, President and CEO of Angiotech. "The Zilver PTX stent platform has shown tremendous mechanical 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."
For the first time, patients in Europe today had access to a highly effective medical treatment for PAD when physicians in several countries completed placements of a CE Mark approved DES designed specifically to treat severe blockages in one of the largest arteries in the leg. Following the evaluation of more than 1,200 patients worldwide during its development, the Zilver PTX stent received CE Mark approval on July 24, 2009 and the first commercial implantations of the device were conducted today in a coordinated effort by physicians in the United Kingdom, Germany, France, Holland, Belgium, Sweden and Spain.
The Zilver PTX is specifically designed and CE Mark 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 implanted in the SFA, such as the ability to resist kinking or fracturing as a result of normal movement of the leg. In addition, the Zilver PTX provides targeted delivery of paclitaxel, a drug proven to reduce restenosis, the re-narrowing of the artery with scar tissue resulting from the trauma of opening the vessel by balloon angioplasty. Originally discovered by Angiotech and licensed to Cook Medical for peripheral artery disease (and other indications) and to Boston Scientific Corporation (BSC) for coronary artery disease (and other indications), Angiotech's paclitaxel technology has been successfully and safely used in millions of patients suffering from coronary artery disease as part of BSC's TAXUS paclitaxel-eluting coronary stent program. As a result of these combined attributes, the clinical trial results suggest that the Zilver PTX stent is a durable and clinically effective peripheral stent that also has an excellent patient safety profile.
The granting of the CE Mark follows the largest clinical evaluation ever conducted for a peripheral vascular DES, led by Dr. Dake. As reported by Cook, the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated highly positive results. Failure rates for the device were very low, with only 8 percent of patients with de novo (new) lesions requiring a re-intervention to reopen the artery within the first 12 months - a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents. Also, specific patient groups that are often difficult to treat, such as diabetics and patients with in-stent restenosis (i.e. patients whose previously placed bare metal stent had become blocked by scar tissue), were shown in the trial to benefit from the Zilver PTX. Importantly, the trial data indicates that the positive results achieved in the first year after treatment are largely maintained through the second year (24 months), an important clinical milestone.
About Peripheral Arterial Disease (PAD)
PAD is one of the fastest-growing and most pervasive diseases of our time, and it is estimated to affect 27 million individuals in Europe and North America.(1),(2),(3) Physical symptoms are only present in approximately one third of these individuals.(1),(4),(5) The 'silent' nature of this condition results in a significant number of patients being diagnosed only after their disease has progressed to a severe stage. Symptomatic PAD initially results in intermittent claudication (IC).(6) IC is characterized by muscle pain or fatigue in the legs that occurs during exercise and is relieved by a short period of rest. Further disease progression can result in critical limb ischemia (CLI)(6),(7), a severe condition associated with chronic pain, ulcers or gangrene due to severe arterial occlusion. In many countries, untreated PAD is the leading cause of leg amputation. Approximately 120,000 to 400,000 leg amputations occur annually due to PAD.(6),(7) Even when treated, current therapies such as bypass surgery and balloon angioplasty(8) are either much more invasive or have shown only limited long-term success rates. PAD, either directly or indirectly, results in a high mortality rate; only 30% of patients are still alive 15 years after initial diagnosis with the disease(4).
The peripheral vascular stent market is estimated to be $200 million in Europe and $1 billion worldwide, with approximately 1/3 of these procedures occurring in the lower limbs. There were approximately 140,000 bypass surgeries performed to treat blockages of the Superficial Femoral Artery in the European Union in 2008 and 200,000 of these surgeries in the United States.
The Zilver PTX drug-eluting stent is an investigational device not available in the United States.