Medtronic receives updated FDA approval for redo TAVR
Medtronic’s self-expanding Evolut transcatheter aortic valve replacement (TAVR) valves have received an expanded approval from the U.S. Food and Drug Administration (FDA) for redo TAVR procedures. This means new Medtronic’s Evolut Pro+, FX and FX+ systems are now all approved to be implanted inside of a failed transcatheter aortic valve.
In addition, the company has launched the RESTORE clinical trial, a new study focused on evaluating the safety and effectiveness of redo TAVR in up to 225 patients with symptomatic bioprosthetic valve failure. Patients will be followed for as long as five years, with researchers tracking both short- and long-term clinical outcomes.
‘An important milestone’
“The redo TAVR indication marks an important milestone for our Evolut TAVR systems, reinforcing our commitment to provide physicians with patient-specific solutions today, and for the future of TAVR,” Jorie Soskin, vice president and general manager of Medtronic’s structural heart business, said in a statement. “With a broader indication than other available options, this expansion, together with the launch of our RESTORE study, build on our differentiated design and unparalleled evidence to advance solutions and elevate care options for heart teams and patients worldwide.”
“FDA approval for redo TAVR with the Evolut system marks a significant milestone in patient care, empowering physicians across the United States to offer a critical treatment option for patients with failing transcatheter heart valves who are at high surgical risk,” added Michael Caskey, MD, attending cardiothoracic surgeon at Abrazo Arizona Heart Hospital in Phoenix. “This advancement also benefits patients considering a new TAVR procedure today, giving patients options for future intervention and has the potential to profoundly improve their long-term outcomes and quality of life.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.