Conor Receives UniStar CE Mark, ISO Certification

Conor Medsystems announced that its UniStar cobalt chromium bare-metal coronary stent received CE mark approval in the European Community for the treatment of de novo coronary artery lesions.

The CE mark for the UniStar stent will lay the foundation for European regulatory approval of its CoStar cobalt chromium paclitaxel-eluting stent. Conor does not plan to immediately commercialize the UniStar stent, but may introduce the product through distributors later this year in countries where bare-metal coronary stents continue to be widely used.

Conor also announced that it received ISO certification of its facility in Athlone, Ireland, for the commercial manufacturing of its coronary stents, including UniStar and CoStar. The ISO 13485 certification reflects that the facility meets the international standards for medical device quality systems applicable to the manufacture of medical devices for clinical use and commercial sale.