Medtronic plc has gained U.S. FDA approval for the use of its CoreValve® System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The CoreValve System is the first transcatheter heart valve approved in the U.S. for VIV procedures in both high and extreme risk patients who have limited options or may otherwise go untreated.
Background
Transcatheter VIV surgery is now a treatment option for patients who require replacement of an earlier implant, but who may be too sick or frail for a second open-heart surgery. The FDA’s approval of Medtronic’s CoreValve for VIV procedures in these circumstances means American citizens have this escape route open to them for the first time.
During the VIV procedure, the CoreValve System is placed inside a failing surgical heart valve with an inner diameter from 17-29 m through a low-profile, 18Fr delivery catheter, which is approved for use with all four CoreValve sizes (23mm, 26mm, 29mm and 31mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic).
The CoreValve system is engineered with a supra-annular valve design, which helps maximize blood flow for patients whose artificial heart valves have shown either stenosis, regurgitation, or both.
The CoreValve System was approved by the FDA in 2014 for patients at extreme risk and high risk for surgery, and received CE Mark for VIV procedures in May 2013. To date the device has been implanted in more than 75,000 patients in more than 65 countries since receiving its original CE Mark approval in 2007. In addition, the CoreValve System offers the broadest range of sizes available to accommodate more patients.
Company comments
“This first-of-its-kind FDA approval showcases Medtronic’s commitment to advancing the TAVR field so that more patients can receive access to this life-saving, minimally invasive therapy,” said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, which is part of the Cardiac and Vascular Group at Medtronic. “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.”
Source: Medtronic, plc
published: March 31, 2015 in: Approval/Clearance, Cardio, Medtronic