Angiotech's licensee, Cook Medical, announces single-arm study reveals 86. 2 percent SFA vessel patency for Zilver PTX
VANCOUVER, May 25 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced Cook Medical, a license holder of Angiotech's paclitaxel technology, presented one-year data at Euro PCR that confirms sustained clinical outcomes with Cook Medical's drug-eluting peripheral stent, Zilver(R) PTX(TM). According to data presented today by Prof. Dierk Scheinert, medical director at Park Hospital Leipzig, 86.2% of all patient subgroups treated with Zilver PTX Drug-Eluting Peripheral Stent demonstrated vessel patency at 12 months(1) without the requirement for an additional intervention.
The data were collected as part of the world's largest clinical study of endovascular treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA). The trial is based on a group of 787 patients, including symptomatic patients, diabetics, and those with the most complex lesions, including long lesions, total occlusions and in-stent restenosis.
The single-arm study also revealed: - A low stent fracture rate of just 1.5 per cent - On average a greater than 50 per cent reduction in restenosis compared to published studies on bare-metal and other drug-eluting stents(2) - Improved clinical outcomes at 12 months according to all four key clinical indicators (ABI, Rutherford Score, walking speed and walking distance)
"I think the patency data look great. A greater than 50 per cent reduction of restenosis is quite impressive and surprising in a positive way," said Dr. Scheinert, a clinical investigator in the trial. "I'm looking forward to the final data from the randomized study, which could confirm this as a major step forward in treating severe lesions within the SFA."
Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention division, commented, "With sustained patency and improved clinical outcomes, the Zilver PTX drug-eluting stent offers both clinicians and patients a revolutionary new alternative. Zilver PTX fundamentally changes the landscape of endovascular SFA treatment."
"Angiotech is excited by these encouraging top line clinical results as our partner, Cook Medical, further validates the effectiveness of paclitaxel for treatment of peripheral vascular disease (PVD)," said Dr. William Hunter, President and CEO of Angiotech. "We are optimistic that the full results of this trial will support Cook's application with the FDA to become the first drug-coated peripheral stent available for the management of the millions of patients suffering from PVD in the United States."
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. This Zilver PTX Drug Eluting Stent Trial is being conducted at various sites in the U.S. and outside of the U.S. in support of Cook's application to the FDA for regulatory approval in the U.S.
Peripheral arterial disease (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.
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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<http://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<http://www.cookmedical.com>.
------------------------- (1) Doppler tests (utilising PVSR less than 2.5) at 12 month check-up confirmed that the patient's vessel remained open in 86.2 per cent of cases
(2) FAST: www.vascularweb.org/Annual_Meeting/Abstracts/2006/Bosiers_The_Femoral_Artery_S; > tenting_Trial_.html Durability: www.clinicaltrials.gov/ct2/show/NCT00530712?term=DURABILITY+II&rank=1<http://www.clinicaltrials.gov/ct2/show/NCT00530712?term=DURABILITY+II&rank=1> Absolute: www.clinicaltrials.gov/ct2/show/NCT00180505?term=absolute&cond=peripheral+arte<http://www.clinicaltrials.gov/ct2/show/NCT00180505?term=absolute&cond=peripheral+arte> rial+disease&cntry1=EU%3ABE&rank=2 STRIDES: www.clinicaltrials.gov/ct2/show/NCT00475566?term=STRIDES+%2B+lammer&rank=1<http://www.clinicaltrials.gov/ct2/show/NCT00475566?term=STRIDES+%2B+lammer&rank=1>
For further information: Rick Smith, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 221-6933, firstname.lastname@example.org
Posted: June 2010