Posts Tagged ‘Sapien’

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June 11th, 2012

FDA Reviewers Raise Questions About Sapien Heart Valve System

FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system was […]


May 2nd, 2012

Real-World Experience with TAVI: Vive la France!

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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 […]


May 2nd, 2012

CMS Issues National Coverage Decision for TAVR

The Centers for Medicare & Medicaid Services (CMS) issued on Tuesday its national coverage decision (NCD) for  transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic […]


February 28th, 2012

Slow Uptake of Transcatheter Aortic Valves: Learning from History?

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs […]


December 1st, 2011

ACC and STS Announce Launch of TAVR Registry

Following the approval of the first device for transcathether aortic valve replacement therapy (TAVR) earlier this month, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have announced the launch of the TVT Registry, a joint initiative that will monitor the rollout of the new technology. The registry was created in response to the […]


November 11th, 2011

TAVI at TCT: Enthusiasm Tempered by Poor Transapical Outcomes

Continued enthusiasm for transcatheter aortic valve implantation (TAVI) with the Edwards’ Sapien device was tempered somewhat by poor outcomes observed in the group of patients for whom the procedure was performed using the transapical instead of the transfemoral approach. Results of 3 new studies from the PARTNER trials and a controversial new trial, STACCATO, were […]


November 7th, 2011

TAVI Approval: An Alternate Perspective

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 […]


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 17th, 2011

Sapien Transcatheter Heart Valve Might Be Delayed

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 […]


July 21st, 2011

Sapien Transcatheter Heart Valve Receives Strong Support from FDA Advisory Panel

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 […]