Boston Scientific’s drug-coated stent, designed to keep arteries from reclogging after heart surgery, could be available for sale in the United States soon. Stents are tiny tubes inserted into arteries during angioplasty. The stent is wrapped around a balloon and attached to a catheter, which is threaded to the appropriate spot in the artery. A physician inflates the balloon, which causes the stent to expand. The balloon is then deflated, and the catheter removed. After a few weeks, tissue forms around the stent, holding it in place.
When patients use regular stents, which are not coated with medicine, arteries reclog about 26 percent of the time, a condition called restenosis. Boston Scientific’s drug-coated Taxus stent, however, has much better results: in a 1,326-patient trial, the stent’s reclogging rate was 7.9 percent. That compares favorably with the only drug-coated stent currently on the market in the U.S., Johnson and Johnson’s Cypher, which has a reclogging rate of 8.9 percent.
"The results are certainly as good as the Cypher results with a more deliverable stent," said Stephen Ellis, principal investigator in the Taxus trial. "This will be a highly competitive stent in the marketplace."
"These are the lowest clinical and angiographic restenosis rates ever seen in a drug-eluting stent," Gregg Stone, M.D., co-principal investigator of the Taxus study, said in an interview with Reuters. "In concert with the enhanced flexibility and deliverability of the Taxus stent, this sets a new standard of care for patients receiving drug-eluting stents," he added.
The results of the study were reported in September 2003. In November, the Circulatory System Devices Panel of the FDA unanimously recommended that the FDA approve the stent for sale in the United States. It is already available in Europe and Canada.
In January, the FDA sent a team of investigators to Boston Scientific’s Ireland facility, the first of two inspections necessary before final approval of the Taxus stent. A second inspection, of the company’s Minnesota manufacturing plant, is scheduled for the first week of February. The company expects full approval by the end of the month.
