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.

September 1st, 2011

How Is TAVI Like a European Toaster?

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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 for taking so long to evaluate products. Some are urging a more “European approach.”

How does the European regulatory process stack up?

  1. Manufacturers that sell devices in Europe must satisfy the “essential requirements” of safety and performance, but they do not necessarily need to show that a device benefits patients.
  2. Clinical efficacy trials are often performed after approval in Europe (but before approval in the United States).
  3. Isolated instances of device complications have disproportionately occurred in countries (i.e., in Europe) that grant earlier approval.
  4. Unlike the U.S., Europe has no centralized process for approving medical devices, so manufacturers are free to seek approval from any EU country. In other words, manufacturers can choose agencies that offer the least-burdensome and fastest reviews.

So does this make you feel better about your toast or more concerned about your TAVI?

All things considered, do we really want to be more European?

Editor’s Note: This post is a response to one by Stephen Fleet titled “TAVI–When Will It Come to an Operating Theater Near Me?”

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4 Responses to “How Is TAVI Like a European Toaster?”

  1. Sanjay Kaul, MD says:
    September 1, 2011 at 1:52 pm

    I like my toast burnt to a crisp, but certainly would not want to apply that to TAVI!

    Unless I see persuasive evidence of innovation leaving our shores from a nonpartisan source, I am not buying the argument.

    The FDA should strengthen, not loosen (like the EU), its regulatory process for approval and marketing.

  2. Richard A. Lange, MD, MBA says:
    September 8, 2011 at 8:17 am

    Sanjay:
    Is it possible to have a stronger and more expedient regulatory process or are these objectives mutually exclusive?

  3. Sanjay Kaul, MD says:
    September 11, 2011 at 8:08 pm

    Rick:
    The idealist in me wants to say yes, but the pragmatist in me doubts it.

    What the FDA needs is:
    More manpower and resources including increased funding by the Congress and user fees from the industry
    Stabilize workload and incentivize the medical reviewers
    Prioritize potentially transformative innovation (Innovation track)
    Minimize interference by the Congress/device industry lobby

    Even if faster approval is possible, the process should be deliberate enough to be sure that decisions are both scientific and sound to accomplish the FDA’s mission of protecting and promoting public health.

  4. Julia K, MS says:
    October 12, 2011 at 2:26 pm

    Do you believe TAVI will increase overall aortic implant volumes in your practice?