Conor Medsystems receives CE Mark for CoStar drug-eluting stent

By Elaine Rigoli

Tampa, Fla., Feb. 17 - Conor Medsystems, Inc. announced Friday that it 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 sell the 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 manufacturer and global distributor of interventional cardiology devices.

In contrast to conventional surface-coated stents, Conor's CoStar cobalt chromium paclitaxel-eluting coronary stent has been specifically designed for vascular drug delivery, according to a company release.

Conor's stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. It 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 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 company said.

"We are very pleased to achieve this significant milestone and begin commercialization of our CoStar stent in Europe," said Azin Parhizgar, PhD, Conor chief operating officer, in a company statement. "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," he added.

"With more than 800,000 angioplasty procedures performed each year in Europe and the market growing at a rate of almost 10% 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, in a statement.

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 to distribute the CoStar stent in Japan and several countries in the Pacific Rim, subject to receipt of regulatory approval.

Conor is currently conducting a clinical trial in the United States of the Costar II to support its application for U.S. regulatory approval of the CoStar stent.

Menlo Park, Calif.-based Conor Medsystems develops controlled vascular drug delivery technologies and has initially focused on the development of drug-eluting stents to treat coronary artery disease.

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