VANCOUVER, June 11 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced Cook Medical, a license holder of Angiotech's paclitaxel technology, has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver(R) PTX(R) Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an anti-proliferative drug, to the target lesion.
Cook's PMA submission includes data from the randomized portion of the ongoing Zilver PTX clinical trial, the largest study of its kind for the endovascular treatment of PAD in the SFA. Encompassing a global single arm registry and a randomized study involving 1,276 total patients including diabetics, symptomatic patients and those with complex lesions, the 479 patients enrolled in the randomized study and the 787 in the single arm study are experiencing clinical improvement, excellent stent durability (i.e., fracture resistance), high rates of event-free survival and freedom from target lesion revascularization. Patency data from the single-arm study was reported at 86.2 percent at 12 months at EuroPCR last month.
"PAD currently affects approximately eight million men and women over the age of 40 in the United States," said Michael Dake, M.D., professor in the Department of Cardiothoracic Surgery at Stanford University Medical School, medical director of the Cath/Angio Laboratories at Stanford University Medical Center and the trial's principal investigator. "The medical community considers percutaneous transluminal angioplasty to be the treatment of choice for patients with PAD, but Zilver PTX shows promise for being a superior method for improving the quality of life of these individuals."
"Filing for pre-market approval with the FDA is an exciting step forward for us in bringing Zilver PTX to market in the United States," said Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention division. "Cook is committed to continually improving the efficacy and safety of our products with the overall aim of improving patient outcomes."
PMA submission is a critical step in the product development process, giving the FDA the appropriate information to evaluate the safety and efficacy of a medical device.
About Zilver PTX
The Zilver PTX stent was CE Marked in August 2009 and has been made available in Europe since September of 2009. It is the first drug-eluting stent indicated for treating PAD in the SFA, an often difficult-to-treat blood vessel in the leg.
Upon deployment, the Zilver PTX stent expands and holds open the artery to restore blood flow. It then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming. In a major advance over previous drug-eluting technologies, the Zilver PTX achieves targeted drug delivery without using a polymer to adhere the drug to the stent body. This eliminates the potential patient risks associated with polymer-coated devices, including clot formation and inflammation.
Cook licenses the rights to use paclitaxel on peripheral stents and other non-coronary medical devices from Angiotech. In the United States, the Zilver PTX Drug-Eluting Stent is an investigational device not available for sale at this time.
PAD is caused by atherosclerosis - the build-up of fatty deposits (atheroma) within the lining of the arteries. The most common symptom of PAD is leg pain during exercise. Over time the arteries may narrow due to atherosclerosis, resulting in a reduction in blood flow. Severely reduced blood flow in the limbs is also known as critical limb ischemia (CLI). It is characterized by leg pain at rest, non-healing wounds, and gangrene, and may lead to amputation of the limb.
Forward Looking Statements
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Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com.
Zilver PTX is a trademark of William Cook Europe A/S.
SOURCE Angiotech Pharmaceuticals, Inc.