Angiotech Pharmaceuticals: Paclitaxel-Coated Coronary Stents From Cook Incorporated Virtually Eliminate In Stent Restenosis.
WASHINGTON--(BUSINESS WIRE)--Sept. 11, 2001
Angiotech Pharmaceuticals (Nasdaq:ANPI) (TSE:ANP) was notified today by Cook Incorporated that coronary stents coated with paclitaxel virtually eliminated in stent restenosis in patients who had undergone repeated interventional therapy to treat blockages in previously stented coronary arteries, a 21-patient pilot study released today at the Transcatheter Cardiovascular Therapeutics conference reported.
According to data presented today by Ivan De Scheerder, M.D., Ph.D., of University Hospitals, Leuven, Belgium, 21 patients who had been treated a minimum of four times for recurring in stent restenosis received a 16 mm Cook V-Flex Plus coronary stent coated with a cytostatic dose of paclitaxel. After six months, no patients in the study exhibited restenosis in the portion of the target vessel where the paclitaxel-coated stent was placed.
"The problem of in-stent restenosis is one of the most pressing issues in interventional cardiology. Demonstrating a high success rate in eliminating recurrent restenosis in the portion of the vessel treated with a paclitaxel-coated stent is extremely encouraging," said John DeFord, Ph.D., president and chief executive officer of Cook Incorporated.
"The problem of previously failed stent procedures represent some of the toughest cases to manage clinically," added William L. Hunter, M.D., MSc, chairman and chief executive officer of Angiotech Pharmaceuticals, which has licensed the use of paclitaxel to Cook. "Showing excellent efficacy in this difficult patient group holds the promise that paclitaxel-coated stents may have applications across a broad range of clinical indications."
In addition to the in stent restenosis pilot study data, Dr. De Scheerder also presented preliminary safety data from patients enrolled in Cook's European-based ELUTES study of paclitaxel-coated coronary stents. Although final results will not be released until next month, Dr. De Scheerder's data confirmed the continuing safety of paclitaxel, a formulation of an antitumor drug currently being evaluated for use in inhibiting the formation of recurring blockages in coronary arteries opened by angioplasty and stenting.
Dr. De Scheerder reported low in hospital complication rates and no late major adverse cardiac events (MACE) related to the stent or its paclitaxel coating in the ELUTES trial data, which will remain blinded until full results are released at the American Heart Association meeting in November.
Under terms of an agreement between Cook Incorporated and Guidant Corporation announced August 20, Cook will develop and manufacture a new paclitaxel-coated coronary stent based on Guidant's latest coronary stent and delivery system technology. Guidant will manage clinical trials and regulatory submissions on Cook's behalf and will act as worldwide distributor for the device pending regulatory approval.
"We congratulate Cook on the execution of a clinical study displaying exemplary results, strongly demonstrating the safety and effectiveness of paclitaxel in treating restenosis," said Ronald W. Dollens, president and chief executive officer of Guidant Corporation. "These results give us even more confidence in the success of our new cooperative agreement in the development and development of drug-coated stents."
With international headquarters in Bloomington, Ind., privately held COOK(r) (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, COOK has been committed to product innovation, skilled hand-craftsmanship and unsurpassed customer satisfaction, earning the company global recognition among medical professionals. Cook Incorporated is acknowledged as an innovator in catheter technology, wire guides, introducer needles and sheaths, stents and stent-grafts, embolization coils, drainage catheters, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction technology and other minimally invasive devices. More than 40 companies in the United States, Europe, Canada, Australia and Asia design, produce, manufacture and distribute COOK brand medical devices to physicians and other medical professionals around the world.
Angiotech Pharmaceuticals (www.angiotech.com) is a Canadian pharmaceutical company dedicated to the development of medical coatings and treatments for chronic inflammatory diseases through reformulation of the anti-cancer drug paclitaxel.
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