CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

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 Valve Summit in Chicago, said that FDA approval would be delayed until April. Borer’s remarks were reported by Wells Fargo medical device analyst Larry Biegelsen, who said he believed that Borer was only speculating and that the most likely scenario is that Sapien will gain approval this month.

An Edwards spokesperson told the Associated Press that the company still anticipates Sapien’s approval in October.

Categories: Cardiac Surgery
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2 Responses to “Sapien Transcatheter Heart Valve Might Be Delayed”

  1. Stephen Fleet, MD says:
    October 17, 2011 at 3:28 pm

    We are falling behind Europe in innovative technology. By the time this gets approved, Europe will already have 2nd and 3rd generation TAVI. The type of patient involved (elderly, co-morbidities) is practically “compassionate use” where delays don’t make a lot of sense.

  2. Angel Flores, MD says:
    October 18, 2011 at 2:57 pm

    it is interesting that the bulk of patients enrolled in pivotal trials before approval for most drugs come from european sites yet in the device world the FDA does not appear to recognize the european experience from well designed trials as valid.

    Competing interests pertaining specifically to this post, comment, or both:
    None.