California medtech giant Edwards Lifesciences (NYSE:EW) announced today that it won FDA approval for its next-generation Sapien XT replacement valve system, with indication to treat both inoperable and high-risk patients with severe symptomatic stenosis.
The Sapien XT valve is a next-generation version of the original Sapien TAVI system, with material changes to the stent frame, the valve leaflet and the catheter to make the device thinner and smaller than its predecessor. Edwards plans to make the device available right away in combination with the NovaFlex+ delivery system for transfemoral access as well as the Ascendra+ system for transapical and transaortic access the company said.
The Sapient XT system has for months been available in markets around the world, including with regulatory approval and subsequent reimbursement wins in Japan as well as CE Mark approval in the European Union.
Sapien XT is the latest in Edwards’ line of TAVI devices to hit the U.S. market, where the company just settled a long-running patent infringement battle against arch-rival Medtronic (NYSE:MDT), an agreement valued at $1 billion in total. Medtronic last month agreed to pay $750 million to put to rest an international patent war over TAVI and other technologies, a deal that included a provision that will see Medtronic pay royalties through April 2022 of at least $40 million annually.
CoreValve was 1st to market with a TAVI device when it won CE Mark approval in the European Union in 2007, but Edwards beat it to the punch in the U.S., winning FDA approval in 2011 for its competing Sapien device.
Edwards’ latest regulatory win comes just days after Medtronic announced FDA approval to market its CoreValve technology for high-risk patients, expanding original approval which was limited to patients who were inoperable or at extreme risk.