Healthcare Industry News: St. Jude Medical
News Release - February 17, 2006
Conor Medsystems Receives CE Mark for CoStar(TM) Drug-Eluting StentFirst Reservoir-Based Controlled-Release Drug Delivery Stent with Bioresorbable Polymer to be Launched in Europe
MENLO PARK, Calif., Feb. 17 (HSMN NewsFeed) -- 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.
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.
This press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation, the statements related to the marketing and distribution of, and the commercial potential for, the company's CoStar stent and the use of company's CoStar stent leading to improved patient care. All forward-looking statements and other information included in this press release are based on information available to Conor Medsystems as of the date hereof, and the company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in the company's Quarterly Report on Form 10- Q for the quarter ended September 30, 2005 filed with the SEC on November 14, 2005, including (i) risks related to the commercialization of company's CoStar stent, including, among other things (a) the risk that the company's CoStar stent may never achieve market acceptance, (b) the risk that the company's manufacturing facilities may be unable to provide an adequate supply of its CoStar stent, (c) the risk that the loss of the company's single source suppliers could interrupt or delay the company's commercialization efforts, (d) the risk that company's distributors' sales and marketing strategies may fail to generate meaningful revenues from sales of the company's CoStar stent, (e) the risk that the company may fail to comply with ongoing regulatory requirements, or that the company may experience unanticipated problems with its CoStar stent, (f) the risk that the company may not obtain adequate levels of reimbursement for its CoStar stent by third-party payors and (g) the risk that the company's competitors may develop and market products that are safer and more effective than the CoStar stent; (ii) risks related to patent infringement, including, among other things, (a) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (1) be enjoined from, or required to cease, the development, manufacture, use and sale of products, including the company's CoStar stent, that infringe the patent rights of others, (2) be required to expend significant resources to redesign its technology so that it does not infringe others' patent rights, which may not be possible, and/or (3) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all, and (b) the risk that intellectual property litigation against the company could significantly disrupt the company's development and commercialization efforts, divert management's attention and quickly consume the company's financial resources; and (iii) the risk that clinical results reported to date may not be indicative of future clinical results and that longer-term results the company obtains with its CoStar stent may not show similar effectiveness. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the company's periodic reports filed with the SEC, including the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005.
Source: Conor Medsystems
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