FDA Approves Sirolimus-eluting Coronary Stent

The U.S. Food and Drug Administration said on Thursday that it has cleared for marketing Johnson & Johnson’s Cypher sirolimus-coated stent for use in coronary angioplasty procedures.

The device, which is made by J&J unit Cordis Corp., is the first drug-eluting stent approved in the U.S.

Physicians and industry analysts expect the new stents to significantly cut the rate of restenosis following angioplasty procedures. Restenosis occurs in about a third of the stenting procedures performed in the United States each year.

“This has profound medical benefits and addresses a very large patient population — more than one million per year in the United States alone,” RBC Capital Markets analyst Phillip Nalbone said.

J&J was expected to receive the U.S. approval following unanimous backing from an FDA panel in October 2002. The firm will hold a monopoly on the drug-coated stent market as competitors Guidant Corp., Boston Scientific Corp. and Medtronic Inc. develop their own products.

“Today’s approval represents a significant step forward in the treatment of heart disease,” said U.S. Health and Human Services Secretary Tommy Thompson in a statement. “Patients who receive this device will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives.”

In an interview with Reuters Health on Thursday, Dr. Samen Sharma, director of the Cardiac Catheterization Laboratory at Mount Sinai Hospital in New York City, said the drug-coated stents would have a significant impact on patient care. He said that currently about 15 percent to 18 percent of patients have to be treated for restenosis following angioplasty. He expects that number to drop to roughly four or five percent with use of the drug-eluting stents.

Dr. Sharma did not conduct any of the Cypher studies, but has participated in the trials for Boston Scientific’s drug-coated stent.

The FDA approval was based primarily on a study of 1,058 patients that showed a significantly lower rate of restenosis and repeat procedures among patients who were treated with the Cypher stent. According to Cordis, the Cypher stent reduced the incidence of restenosis by more than 90% compared with conventional metal stents.

The agency approved the Cypher stent under an expedited review for use in native coronary arteries with reference diameters of 2.5mm to 3.5mm and lengths of 8, 13, 23, 28, and 33mm.

The FDA has asked Cordis to conduct a 2,000-patient, post-approval study to evaluate patients from ongoing studies and assess the long-term safety and effectiveness of the Cypher stent. It also has asked the company to look for rare adverse events that may occur with use of the product.

Cypher’s cost is expected to be roughly three times that of bare metal stents. But J&J recently presented data at the American College of Cardiology that showed that long-term efficacy and a reduced need for repeat procedures resulted in net savings of more than $2,500 per patient annually compared with bare metal stents.

“The overall amount of money that will be spent per patient per year will be significantly lower because of a decrease in the repeat procedures,” Mount Sinai’s Dr. Sharma said.

The Centers for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services, has approved incremental reimbursement for the new stents for Medicare patients, effective April 1, 2003.

Cordis noted that it is in discussions with Medicaid, the federal health program for the poor, and private insurance firms to gain coverage and incremental reimbursement for drug-eluting stents.

The Cypher stent received market clearance in the European Union in April 2002. It is also approved for sale in Canada and throughout the Middle East, Latin America and the Asia-Pacific region.