FDA Approves Sales of New Heart Stent

In a major advance for heart patients, the government has approved an eagerly awaited type of stent that emits a drug to help keep newly unblocked arteries from reclogging. But it has a big price tag.

Cardiologists are expected to quickly begin using the new Johnson & Johnson Cypher stent in many of the 800,000 Americans who undergo artery-clearing angioplasties every year.

The Food and Drug Administration approved sales of the drug-coated stent Thursday after studies suggested it could cut by almost 60% the chance of a heart attack or need for additional treatment compared to today’s stents.

“This is a significant breakthrough,” said FDA Commissioner Mark McClellan, using a term rarely uttered at the cautious agency. “This could have a substantial impact on the course of care” for many heart patients.

But with a list price of $3,195 -- three times the cost of a regular stent -- hospitals are worried about how they will afford the device. Most stent recipients are older patients covered by the federal Medicare program. Medicare is raising its stent reimbursement, but not enough to cover all of the extra cost, especially if patients need more than one stent.

“This is a very significant advance,” said American Heart Assn. president Dr. Robert Bonow, a cardiologist at Northwestern Memorial Hospital in Chicago.

Not every angioplasty candidate needs the new, more expensive stent, Bonow stressed -- because the cheaper, regular kind works very well in the majority of patients.

During angioplasty, cardiologists thread a balloon inside clogged coronary arteries and push the blockage aside. Then stents, a type of metal scaffolding, are inserted to keep the artery from reclogging.