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 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 […]
March 2nd, 2012
Four Cardiovascular Societies Release Criteria for TAVR Programs and Operators
Larry Husten, PHD
A newly released statement contains detailed recommendations about the requirements necessary for hospitals and physicians to participate in transcatheter aortic valve replacement (TAVR) programs. The expert consensus document was released jointly by the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS) and the Society for Thoracic […]
November 3rd, 2011
Sapien Transcatheter Aortic Heart Valve Gains FDA Approval
Larry Husten, PHD
After much anticipation and drama, the FDA has approved the Sapien transcatheter heart valve (THV). The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the manufacturer of the device. Details about the approval are scarce. The FDA said the Sapien THV has been “approved for patients who are not eligible for […]
October 19th, 2011
U.K. Registry Tracks Long-Term TAVI Outcomes
Larry Husten, PHD
The excitement over transcatheter aortic valve implantation (TAVI) has been tempered by the absence of long-term outcomes data and concerns that the procedure may not live up to its initial promise in real-world settings. Now a report from the U.K. TAVI Registry, which keeps track of every TAVI procedure performed in the U.K., sheds new […]
June 27th, 2011
TAVI: Playing in the Sandbox Together
Richard A. Lange, MD, MBA and L. David Hillis, MD
Kudos to the the American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) for getting ahead of the game by rolling out a joint position statement regarding transcatheter aortic valve implantation (TAVI) before the FDA panel convenes in July to consider approval of the procedure. It’s a terrific first step to avoid some of the […]
September 20th, 2010
What Does Gregg Stone Most Want to See at TCT This Year?
Gregg W Stone, MD
CardioExchange asked Gregg Stone, Director of the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting, what he thinks will be the three most important trials or topics presented at this year’s conference. The most important and impactful trial is undoubtedly the PARTNER trial, which is a large randomized trial of transcatheter aortic valve implantation compared to medical therapy […]