What implication does the protocal change (reducing the proportion of patients with multi-vessel disease from 50% to 25%) have on its ability to get a multi-vessel label? Specifically, is the ability to get a multi-vessel label significantly reduced?
>> Conor Medsystems Receives CE Mark for CoStar(TM) Drug-Eluting Stent
Friday February 17, 9:04 am ET
First Reservoir-Based Controlled-Release Drug Delivery Stent with Bioresorbable Polymer to be Launched in Europe
MENLO PARK, Calif., Feb. 17 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc., (Nasdaq: CONR ), a pioneer in next generation drug-eluting stents, today announced that it received Conformite Europeen (CE) Mark approval for its CoStar(TM) cobalt chromium paclitaxel-eluting stent for the treatment of coronary artery disease. CE Mark approval enables Conor Medsystems to commercialize its CoStar stent in the European Union and other countries accepting CE Mark. Beginning immediately, Conor's CoStar stent will be marketed and distributed in these markets by Biotronik AG, a leading manufacturer and global distributor of devices in the area of interventional cardiology.
"Clinical studies of the CoStar stent have shown significant patient benefits and demonstrated the importance of controlled drug delivery for the treatment of restenosis," said Keith D. Dawkins, M.D., FRCP, FACC, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom. "In addition to positive clinical results, the CoStar stent has consistently demonstrated an excellent safety profile, and the use of bioresorbable polymers ensures that no permanent polymer residue or drug remains at the target site."
In contrast to conventional surface-coated stents, Conor's CoStar cobalt chromium paclitaxel-eluting coronary stent has been specifically designed for vascular drug delivery. The CoStar stent differs from conventional surface- coated drug-eluting stents as it is not coated. Instead, Conor's stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. In addition, the CoStar stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers or drug at the target site.
The British Standards Institute (BSI) issued CE Mark approval of the CoStar stent based on a review of the preclinical and clinical data indicating the safety and efficacy of the CoStar stent in the treatment of coronary artery disease and reducing the rate of restenosis. In particular, CE Mark approval of Conor's CoStar stent was supported by data from the company's pivotal EuroSTAR clinical trial, as well as other supporting clinical trials including the PISCES and COSTAR I studies. The CoStar stent is being commercially manufactured at Conor's ISO-certified facility in Ireland.
"We are very pleased to achieve this significant milestone and begin commercialization of our CoStar stent in Europe," said Azin Parhizgar, Ph.D., Chief Operating Officer of Conor. "We believe that the unique design and technology of Conor's drug-eluting stent represents a significant innovation in the treatment of patients with coronary artery disease and that the use of Conor's CoStar stent will lead to improved patient care."
"With more than 800,000 angioplasty procedures performed each year in Europe and the market growing at a rate of almost 10 percent annually, there is tremendous commercial potential for Conor's CoStar stent," said Marlou Janssen, Vice President, Sales and Marketing of Biotronik Vascular Intervention, Biotronik AG. "We are pleased to begin marketing and distribution of Conor's pioneering vascular drug delivery technology."
Biotronik has the right to market and distribute the CoStar stent in Europe, Latin America and certain countries in Asia. Interventional Technologies, Pvt., Ltd. has the right to distribute the CoStar stent in India, and affiliates of St. Jude Medical, Inc. have the right distribute the CoStar stent in Japan and several countries in the Pacific Rim, subject to receipt of regulatory approval.
Conor is currently conducting a U.S. pivotal clinical trial, COSTAR II, to support its application for U.S. regulatory approval of the CoStar stent. The CoStar stent is not available for sale in the United States where it is an investigational device limited by law to investigational use.
About Conor Medsystems
Conor Medsystems, Inc. develops innovative controlled vascular drug delivery technologies, and has initially focused on the development of drug- eluting stents to treat coronary artery disease. For further information on Conor Medsystems and controlled vascular delivery, visit www.conormed.com.
About Biotronik
Biotronik is a leading European manufacturer of biomedical technology with a worldwide market presence. The company offers a complete line of products for diagnosis, treatment, and advanced therapy support in the areas of cardiac rhythm management, electrophysiology and vascular intervention. The field of vascular intervention consists of guide wires, balloon catheters and stent systems for coronary and peripheral applications. For more information, visit Biotronik's website at www.biotronik.com. <<
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