FDA Statement on Coronary Drug-Eluting Stents

The FDA issued a statement September 14, 2006 following the controversy from papers presented at the presented at the March 2006 American College of Cardiology Scientific Sessions in Atlanta GA - (Basket-Late study) and more recently the Sept 2006 European Society of Cardiology Annual Meeting/World Congress of Cardiology Meeting in Barcelona Spain - (the Camenzind meta-analysis).

FDA Statement on Coronary Drug-Eluting Stents

At this time, FDA believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year.

This was the conclusion of the statement however the FDA is working closely with the two manufacturers - read Boston Scientific and Johnson and Johnson to monitor long term clinical studies and will soon hold a public panel on the subject.

See related posts:

Do Drug Eluding Stents DES increase Deaths

NEJM — Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction