Sapien THV gets “Access all Areas” Nod from FDA

Edwards Lifesciences and Medtronic are the two undisputed biggest names in transcatheter aortic valves, yet Edwards seems to have been getting all the good news recently. The two parties remain at loggerheads over patent claims and Medtronic’s CoreValve became the subject of an injunction in Germany only last month. Now Edwards’  Sapien Transcatheter Heart Valve (THV) has gained extended labelling approved by the U.S. FDA, which means physicians will no longer be limited to implantation via a femoral or transapical access point.


Transcatheter Aortic Valve Implantation/Replacement (TAVI/R) in the United States, was originally restricted to patients considered inoperable by conventional “open heart” means, due to their health status. In October 2012 that restriction was relaxed a bit to include patients considered only to be “high risk” rather than inoperable. The approval was previously limited to insertion through the transfemoral approach or transapical approach. The new labeling removes references to specific access points now making it available for inoperable patients who need an alternate access point. In effect this opens up the potential for insertion in the arm, which is fast becoming the access point of choice in markets where it is so approved, namely Europe.

This is a good example of the power of registry data, Edwards having relied heavily on its Transcatheter Valve Therapy Registry (TVTR) in the United States and THV device registries in Europe.  It combined registry findings with data from FDA-approved clinical studies, and peer-reviewed medical journals.

There was seemingly no evidence that the device performs differently or has a different benefit-risk profile based on the access point.


FDA Comments

“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, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

Source: FDA press release here