Medtronic Wins FDA Approval for Redo-TAVR Procedure

Medtronic has received U.S. Food and Drug Administration (FDA) approval for the expanded Redo-TAVR indication of its Evolut transcatheter aortic valve replacement (TAVR) system.

The approval allows implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed, previously implanted TAV and follows the CE mark for the Evolut PRO+, FX, and FX+ systems. The Redo-TAVR surgery is indicated for patients with failure of any TAV, including but not limited to severe aortic stenosis with high risk for open-heart surgery.

“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,” said Dr. 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.”

“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,” added Jorie Soskin, vice president and general manager of the Structural Heart business within the Cardiovascular Portfolio at Medtronic. “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.”

Medtronic also began the RESTORE study to evaluate outcomes of Redo-TAVR in patient with symptomatic bioprosthetic valve failure. The pivotal study will enroll 225 subjects and follow them up for five years, focusing on immediate and long-term clinical outcomes.

The study hopes to assess 30-day procedural success rates, one-year freedom from mortality and stroke, and additional measures of safety, technical success, and quality of life.