Medtronic (NYSE:MDT) today scored a double for its CoreValve replacement heart valve, after Japanese regulators approved the transcatheter aortic valve implant and the FDA expanded its indication to include "valve-in-valve" procedures.
The new valve-in-valve indication covers the use of CoreValve in replacing their previously implanted surgical valves. The approval "expands the authorized use of the device to patients in need of this replacement who also are at high or extreme risk for complications associated with traditional open-heart surgery," the FDA’s Center for Devices & Radiological Health said.
"The CoreValve system offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high," Dr. William Maisel, deputy center director for science and CDRH chief scientist, said in prepared remarks. "The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology."
Earlier today Medtronic said that regulatory officials in Japan approved CoreValve for sale there.
The FDA said it based its decision in part on a 143-patient trial that showed an estimated rate of survival without major stroke of 95.8% at 30 days and 89.3% at 6 months – numbers comparable to the results for 1st-time TAVI procedures, according to the federal safety watchdog.
Medtronic is required to follow study participants up to 5 years in a post-market study, the FDA said.
“This 1st-of-its-kind FDA approval showcases Medtronic’s commitment to advancing the [TAVI] field so that more patients can receive access to this life-saving, minimally invasive therapy,” Medtronic’s heart valve therapies general manager Rhonda Robb said in a statement. “The CoreValve design is uniquely suited for valve-in-valve implantation due to its supra-annular design. We are pleased to be able to provide physicians and patients with another treatment option to replace surgical heart valves when needed.”