Posts Tagged ‘transcatheter valve therapy’

February 20th, 2013

Small Study Explores Expanded Use for TAVI in Native Valve Aortic Regurgitation

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

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

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

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

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


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?

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 […]