WASHINGTON (AP) - A much-anticipated new type of stent that keeps clogged heart arteries propped open by emitting a drug won federal approval Thursday, a move that could dramatically change heart-disease treatment - but at a much higher cost.
The Food and Drug Administration approved the sale of Johnson & Johnson's Cypher stent after studies comparing it with standard treatment showed the new stent significantly reduced the chance of heart attack or the need for additional surgery.
Cardiologists have eagerly awaited the new type of stent and are expected to begin using it quickly in many of the estimated 800,000 Americans who undergo artery-clearing angioplasties every year.
But with an estimated price tag of $3,000, three times the cost of a traditional stent, hospitals have been worrying about the device's affordability. Private insurers are expected to cover the cost. But most stent recipients are older patients covered by the federal Medicare program. Medicare is raising its stent reimbursement, but not enough, hospitals say, to cover all the extra cost - especially if patients need more than one stent, as many do.
During an angioplasty, cardiologists thread a balloon inside clogged coronary arteries and push the blockage aside. Then stents, a type of metal scaffolding, often are inserted to help keep the artery from re-clogging.
They're not perfect - up to 30 percent of patients suffer another blockage within a year. So scientists tried coating stents with certain medications in an effort to make them work better.
Cypher, made by Johnson & Johnson subsidiary Cordis Corp., uses the drug sirolimus, normally used to prevent organ rejection in kidney transplants. The theory is that when the artery slowly absorbs some of the drug, it may help control inflammation, thus fighting a new clog.
In one study, 1,058 angioplasty patients were given either the Cypher stent or a plain stent made by the same company. Immediately after the angioplasty, patients did equally well. But after nine months, only 4 percent of patients who had the drug-emitting stent had suffered a re-clog, compared with 17 percent of patients who got the regular stent.
The new stents aren't for everybody, the FDA cautioned. So far, they come in sizes intended to clear only certain-sized blockages, and won't fit small arteries. Some patients can't tolerate sirolimus, and those who get the drug-emitting stent will need certain blood-thinning drugs for at least several months following the procedure, the FDA said.
