CardioExchange Archive

November 7th, 2011

TAVI Approval: An Alternate Perspective

Norman Silverman, md

The FDA’s decision to release for general use the Sapien transcatheter aortic heart valve implantation (TAVI) technology ends the conflicting reports of either imminent approval or six months delay for further evaluation. This had created quite a stir. Self-proclaimed patient advocates aver that enough vetting has occurred and decry that excessive regulatory obstruction is denying the American […]

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November 3rd, 2011

FDA Approves TAVR But Remains in the Crosshairs

Richard A. Lange, MD, MBA

I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons and […]

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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 […]

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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 […]

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October 17th, 2011

Sapien Transcatheter Heart Valve Might Be Delayed

Larry Husten, PHD

Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC/AATS Heart […]

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September 1st, 2011

How Is TAVI Like a European Toaster?

Richard A. Lange, MD, MBA and L. David Hillis, MD

Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the FDA […]

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August 31st, 2011

TAVI—When Will It Come to an Operating Theater Near Me?

Stephen Fleet, MD

At the ESC meeting in Paris, Gerhard Schuler from Leipzig reviewed the current indications for Transcatheter Aortic Valve Implantation (TAVI). TAVI is considered appropriate for: Inoperable patients with severe aortic stenosis with a baseline 1-year mortality risk of 50%.  Patients with severe aortic stenosis and a surgical risk of greater than 15%. Valve-in-valve implantation for degenerated bioprosthetic […]

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July 21st, 2011

Sapien Transcatheter Heart Valve Receives Strong Support from FDA Advisory Panel

Larry Husten, PHD

The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve (THV) for use in patients with inoperable severe aortic stenosis and with no comorbidities precluding benefit from correction of the stenosis. By large majorities, the panel voted that the procedure was safe (7-3), that […]

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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 […]

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June 10th, 2011

TAVR: A Stroke of Genius or Bad Luck?

Richard A. Lange, MD, MBA and L. David Hillis, MD

After presentations at the ACC and American Association for Thoracic Surgery 2011 meetings, the PARTNER A results are finally published. PARTNER A compared  transaortic valve replacement (TAVR, also known as TAVI) with surgical aortic valve replacement (AVR) in patients with aortic stenosis who were eligible for AVR but considered to be at high surgical risk . At 1-year […]

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