Conor Medsystems' UniStar cobalt chromium bare-metal coronary stent has received CE mark for the treatment of de novo coronary artery lesions. The company does not plan to commercialise the UniStar stent immediately, but may introduce the product through distributors later this year in countries where bare-metal coronary stents continue to be widely used.
In February, Conor filed a CE mark application for its CoStar cobalt chromium paclitaxel-eluting stent. The company anticipates receiving CE mark approval of the CoStar stent in the second half of 2005. Pending regulatory approval, the CoStar stent will be marketed in Europe, Latin America and parts of Asia by the company's distribution partner, Biotronik. In March, a limited market release of the CoStar stent began in India through Conor's South Asian distribution partner, Interventional Technologies, Pvt, Ltd.
Conor has also received ISO certification of its facility in Athlone, Ireland, for the commercial manufacturing of its proprietary coronary stents including the UniStar stent and the CoStar cobalt chromium paclitaxel-eluting coronary stent.
"We are delighted to have received CE Mark approval for UniStar, which lays the foundation for European regulatory approval of our CoStar stent," said Dr Frank Litvack, Chairman and CEO of Conor.
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