FDA Panel Recommends Approval of New DES
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October 11, 2007 By Grendel Burrell [1]
Gaithersburg, MD: A U.S. Food and Drug Administration (FDA) advisory committee has unanimously recommended Medtronic’s (www.medtronic.com) Endeavor® drug-eluting stent (DES) for conditional approval as a treatment for coronary artery disease (CAD). The Endeavor® stent could become the first new DES to be introduced in the United States since 2004.
The FDA's Circulatory System Devices Panel vote recommended the Endeavor® stent for approval and came with conditions related to product labeling and post-market study requirements. The advisory committee recommended that the product's labeling reflect the clinical trial protocol use of dual anti-platelet therapy and the professional society guidelines on the use of dual antiplatelet therapies. The panel also recommended a post-market registry of >5,000 patients followed for a minimum of five years with a primary endpoint of very late stent thrombosis and a secondary endpoint designed to evaluate death and MI.
Asked to comment on the Advisory Panel’s decision, Dr. David Cohen, Director of Cardiovascular Research, Saint-Luke's Mid America Heart Institute, Kansas City, MO, told WikiDoc, “I believe that the Endeavor® stent will be of value to the interventional cardiology and to our patients. Although the data are still not entirely definitive, most of the available data would suggest that the Endeavor® stent has a very low rate of very late stent thrombosis (i.e., events beyond 1 year). For many patients, life long dual antiplatelet therapy is not a viable option for prevention of late thrombotic events. For these patients in particular, having an additional option that appears to be quite safe beyond 1 year is an important advance. For these reasons, I believe having a third drug-eluting stent in our armamentarium is of considerable value.”
Cohen continued, “That said, we are still in the early phases of understanding all of the issues with drug-eluting stents. With increasing use in off-label populations, it will be critical to monitor for these late complications in particular in an attempt to better understand how this new stent compares with the established competitors.”
2,100 patients have been treated with the Endeavor® stent as participants in the ENDEAVOR Clinical Program, including 1,287 patients studied for two years and 675 patients studied for three years. Martin B. Leon, Columbia University Medical Center, N.Y., served as principal investigator of the ENDEAVOR III and ENDEAVOR IV Clinical Trials.
The Endeavor® stent is made of a cobalt alloy and is built on the same platform as Medtronic's Driver bare metal stent. In addition to the cytostatic drug zotarolimus (ABT-578), the Endeavor® stent is coated with phosphorylcholine (PC) technology, a polymer designed to simulate the outside surface of a RBC and mimic the structure of the natural cell membrane.
Commercially available in >100 countries outside the United States, the Endeavor® stent remains an investigational device in the US and is not yet approved for commercial used despite the recommendations of the Advisory Panel.
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
