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Cordis to Stop Making Cypher, Nevo Stents

— Cypher, the first drug-eluting coronary stent to receive FDA approval, will be discontinued at the end of the year, according to manufacturer Cordis.

MedpageToday

Cypher, the first drug-eluting coronary stent to receive FDA approval, will be discontinued at the end of the year, according to manufacturer Cordis.

The company, a Johnson & Johnson subsidiary, will also stop development of the Nevo sirolimus-eluting coronary stent.

The Cypher sirolimus-eluting stent revolutionized percutaneous coronary intervention following its approval in Europe in 2002 and in the U.S. in 2003.

Approval was based on results of RAVEL, the first multicenter, double-blind, randomized trial of drug-eluting stents.

Also being discontinued is the Cypher Select Plus drug-eluting stent.

"We see greater opportunities to benefit patients and grow our business in other areas of the cardiovascular device market," said Seth Fischer, worldwide chairman of Cordis, in a press release.

Fischer noted that dynamics in the drug-eluting stent market have changed considerably in recent years and continue to evolve in areas such as demand, pricing, and reimbursement, and regulatory requirements for breakthrough new technologies.

In addition, unlicensed competition from products that infringe on Cordis patents, both owned and licensed, has eroded Cypher stent pricing, sales, and market share, and has dampened the prospects for Nevo stent commercialization, according to the release.

The discontinuation of Cypher and Nevo will result in the closure of two manufacturing facilities, one in Cashel, Ireland, where the Nevo stent was to be produced, and the other in San German, Puerto Rico, the manufacturing site for the Cypher products.

In May, Johnson & Johnson announced it would seek approval of 11 new drugs between now and 2015, including medicines for Alzheimer's disease, diabetes, and arthritis.