Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - January 26, 2007

New Requirements for Drug Eluting Stents Unveiled at CRT 2007

First Time FDA Device Officials Release and Discuss Future Implications

Washington, DC - January 26, 2007 (HSMN NewsFeed)- Key participants in the December 2006 Food and Drug Administration (FDA) advisory panel meetings on drug-eluting stents (DES) reveal new requirements regarding use of the stents at CRT 2007, a three-day series of scientific sessions for interventional cardiologists, sponsored by the Cardiovascular Research Institute at Washington Hospital Center, March 7- 9, 2007 in Washington, DC.

CRT 2007 will be the first time these requirements are released and the first cardiology meeting to address consequences of the recommendations made by the FDA advisory panel.

At this year’s lead off session “Workshop with the FDA” FDA officials meet with thought leaders in research, interventional cardiology and industry to explore next steps with a focus on bench and pre-clinical testing and clinical trial design.

Moderators include Bram Zuckerman, MD, director of the FDA Division of Cardiovascular Devices, Ron Waksman, MD, director, Experimental Angioplasty at Washington Hospital Center, William Maisel, MD, Cardiovascular Division, Beth Israel Deaconess Medical Center, Robert Califf, MD, Cardiovascular Medicine, Duke University Medical Center, and Mitchell Krucoff, MD, director, Ischemia Monitoring Laboratory, Duke University Medical Center.

During the full day session, a panel of more than 20 experts will discuss FDA expectations, unanswered issues in current practice, appropriate adjunct pharmacological therapy for DES, how to evaluate the variety of new DES platforms and FDA requirements for new DES.

“Workshop with the FDA” runs from 10:45 a.m. through 6:30 p.m. at the Omni Shoreham Hotel, 2500 Calvert Street, NW, Washington, DC. For more information about CRT 2007, its scientific and clinical sessions and live case schedule, go to www.CRTonline.org.


Source: Cardiovascular Research Institute

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