September 23rd, 2013

Using Registry Data, FDA Expands Indication for Edwards’ Sapien Transcatheter Heart Valves

Relying on an important new source of information, the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points and therefore allows for alternative access points such as the subclavian.

The most significant part of the FDA’s announcement may be not the label change itself but the source of the data supporting the claim — the Transcatheter Valve Therapy Registry (TVTR). The TVTR, which is run by the American College of Cardiology and the Society of Thoracic Surgeons, has emerged as an model of cooperation between the FDA, industry, and medical organizations. The TVTR data, according to the FDA, show no evidence that the access point changed the benefit-risk profile or the device.

“Just two years after the THV entered the market for a specific patient population, data from the TVTR was used to support FDA approval that expands patient access to a life-saving therapy,” said Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “Medical device registries like the TVTR not only play an important role in the FDA’s post market surveillance system, they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy. “

“Leveraging clinical research inside the framework of a device registry to expand access to therapy for more patients is a new paradigm for the FDA, researchers, registry sponsors and the medical device industry,” said Shuren. “We believe this approach can be used with future well-designed device registries to speed patient access to important, well-evaluated therapies.”

2 Responses to “Using Registry Data, FDA Expands Indication for Edwards’ Sapien Transcatheter Heart Valves”

  1. Wow. Paradigm change and good for all parties. This is one reason why we have spent so much time in developing the Registry and working with all the stakeholders. More work to do but this is delivering on a basic use of the Registry – bringing new technology to patients quicker but based on valid independently collected data. The old system of off-label use with no data collection would have not allowed for this FDA action, plus the CMS coverage that automatically follows. Please read more about the TVT Registry: Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL et al. The STS-ACC Transcatheter Valve Therapy National Registry: A New Partnership and Infrastructure for the Introduction and Surveillance of Medical Devices and Therapies. J Am Coll Cardiol 2013;62:1026–34.
    The burden of data collection of TAVR sites for the Registry does have clear positive impact on their ability to expand their patient population with evidence based medicine. Other benefits will follow…

  2. Judith Andersen, AB, MD says:

    Could not agree more. Kudos to the investigators, clinicians and regulators responsible for this. Have had some experience of the benefit of transcatheter valve therapy for patients who could clearly not have survived surgical therapy — and am really pleased that the coordination of data collection that this new partnership has created will make this therapy available to most of the patients who need it. There are still patients off the grid — many of whom do not appear to have access to the sites where transcatheter intervention is available, and we need to publicize the success of these procedures, the value of this registry, and the sites at which transcatheter intervention is available, to physicians and families still not aware of this option. Thanks to all the participants in this endeavor.