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
Related posts:
- Clinical and Angiographic Outcomes After Placement of Multiple Overlapping Drug-Eluting Stents in Diffuse Coronary Lesions
- NEJM — Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction
- Do drug eluting stents DES increase deaths?
- Abbott Begins Early International Launch of XIENCE™ Everolimus Eluting Coronary Stent System
- Stent Clinical Trial Taxus® and Cypher® in Diabetics
