Conor Medsystems, Inc., manufacturer of drug-eluting stents, received Conformite Europeen (CE) Mark approval for its CoStar 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," Keith D. Dawkins, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom said adding, "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."
According to the company release, 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, claims the release.
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.
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.