Medtronic (NYSE: MDT) announced today that it received FDA approval for the expanded redo-TAVR indication of its Evolut system.
This allows for the implantation of a new Evolut transcatheter aortic valve replacement (TAVR) system inside any failed previously implanted TAV. It comes on the heels of CE mark for the Evolut Pro+, FX and FX+ systems for this indication.
Redo-TAVR is indicated for patients experiencing failure of any TAV. That includes severe aortic stenosis patients at high risk for open-heart surgery.
In addition to the approval, Medtronic also launched the RESTORE study. It evaluates the outcomes of redo TAVR in patients experiencing symptomatic bioprosthetic valve failure.
The company plans to enroll 225 participants and follow them for up to five years, evaluating both immediate and long-term clinical outcomes. This study aims 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.
Medtronic said the study underscores its commitment to improving solutions for complex cardiovascular conditions.
“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,” said Jorie Soskin, VP and GM of the Structural Heart business 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.”
