Medtronic Earns CE Mark for Evolut Redo TAVI Procedure

Medtronic has obtained CE mark approval for the expanded redo TAVI (transcatheter aortic valve implantation) indication of its Evolut PRO+ and FX TAVI systems.

The approval means a new Evolut TAV can be implanted inside any failed previously implanted TAV in the EU. The redo TAVI surgery is indicated for patients with severe aortic stenosis with any TAV’s failure, regardless of the manufacturer, and those at high risk for open-heart surgery.

Severe aortic stenosis happens when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Severe aortic stenosis often reduces a patient’s quality of life and limits daily activities.

If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.

“The CE Mark approval for the Evolut TAVI system’s redo TAVI procedure is great news for physicians working in this field, but most importantly for patients with failing transcatheter heart valves, who now have a crucial new treatment option” said Professor Dan Blackman, consultant interventional cardiologist, Leeds Teaching Hospitals NHS Trust, United Kingdom.  “This minimally invasive procedure not only offers an alternative for patients at high risk for surgery but also underscores the commitment to improving outcomes and extending the benefits of TAVI therapy.”

Evolut TAVI systems are presently indicated for implant in symptomatic severe aortic stenosis patients across all risk categories in the EU and U.S.

“Redo TAVI indication builds upon the Evolut platform’s proven valve performance and durability to offer safe and reliable lifetime management options, providing physicians exceptional patient outcomes today, while maintaining important options for the future,” said Jorie Soskin, vice president and general manager, Structural Heart, which is part of the Cardiovascular Portfolio at Medtronic. “This approval is a testament to Medtronic’s ongoing commitment to advance patient care and expand treatment options and access around the globe.”

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