January 20th, 2014
FDA Grants Earlier Than Expected Approval for Medtronic’s CoreValve
Larry Husten, PHD
The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. The approval was based largely on results from the Extreme Risk Study of the CoreValve […]
October 29th, 2013
Pivotal Results for Medtronic’s CoreValve
Larry Husten, PHD
Key data on what will likely be the second transcatheter aortic valve to gain approval in the U.S. were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open […]
September 23rd, 2013
Using Registry Data, FDA Expands Indication for Edwards’ Sapien Transcatheter Heart Valves
Larry Husten, PHD
Relying on an important new source of information, the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points […]
July 12th, 2013
Medtronic Faces Removal of CoreValve Transcatheter Heart Valve from German Market
Larry Husten, PHD
In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany. Medtronic said it would appeal the […]
February 20th, 2013
Small Study Explores Expanded Use for TAVI in Native Valve Aortic Regurgitation
Larry Husten, PHD
As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic […]
October 24th, 2012
TCT: Impressive Survival Benefit for TAVR in Inoperable Patients at 3 Years
Larry Husten, PHD
At the TCT meeting in Miami, Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At 3 years, the mortality advantage continued to grow for TAVR over standard therapy. All-cause mortality at 3 years: 80.9% […]
October 22nd, 2012
FDA Approves the Sapien Transcatheter Heart Valve for High-Risk Patients
Larry Husten, PHD
The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but are at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were […]
July 31st, 2012
TAVI: Belgian Researchers Slam Evidence Base and Overuse in Europe
Larry Husten, PHD
The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are deemed inoperable […]
July 16th, 2012
The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?
Larry Husten, PHD
One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR (transcatheter aortic valve replacement) about the time when the procedure edged closer to U.S. approval. Now, in […]
May 2nd, 2012
Real-World Experience with TAVI: Vive la France!
Richard A. Lange, MD, MBA and L. David Hillis, MD
A study of data from FRANCE 2, a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI), has now been published in the New England Journal of Medicine. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore reflects “real-life” experience with TAVI in patients with […]
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