Dr. Leon is Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.He trained me at the Washington Hospital Center between 1996 and 1998, which was followed by a faculty position as head of experimental revascularisation at the centre between 1998 and 2000.Dr. Leon has co-authored over 1550 publications, has performed over 10,000 interventional procedures, and has had a major impact as a thought-leader and innovator in the expanding sub-specialty of interventional cardiovascular device and drug therapies.Vijayaraman discloses being a speaker or consultant or being involved in research for Medtronic, serving as a consultant for Boston Scientific, and having a patent pending for a His-bundle pacing delivery tool.Also, M. Leon has contributed to many other branches of cardiology as well'.PARTNER 3, for which he is co-principal investigator, has no maximum age cutoff.
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Center for Interventional Vascular Therapy
Edwards Lifesciences announced that the FDA has approved its Sapien 3 balloon-expandable transcatheter aortic heart valve for the treatment of high-risk patients with severe, symptomatic aortic stenosis. The device was approved based on data from a cohort of 583 high-risk patients from 29 U.S. sites in the PARTNER II trial, according to the release. "The Sapien 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes," Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center; professor of medicine at Columbia University College of Physicians and Surgeons; and co-principal investigator of the PARTNER II trial, said in the release. "The PARTNER II study concluded that this new valve reduced several complications associated with the procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices."
The Sentinel, a dual-filter embolic protection device, won FDA clearance for use during transcatheter aortic valve replacement, manufacturer Claret Medical announced. Sentinel was designed to filter out debris dislodged during the TAVR procedure so it doesn't travel up to the brain. With FDA approval via the agency's de novo classification pathway, the manufacturer will now launch the device in TAVR centers of excellence across the U.S. "The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking," Martin Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital -- and chairman of the SENTINEL Trial Clinical Steering Committee -- said in the press release announcing the FDA approval.