Medtronic has announced it has received CE mark for the expanded redo transcatheter aortic valve implantation (TAVI) indication of the Evolut PRO+ and FX TAVI systems. This approval allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed previously implanted TAV.
The redo TAVI procedure is indicated for the failure of any TAV, regardless of the manufacturer, amongst patients with severe aortic stenosis and for those at high-risk for open-heart surgery.
“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 Dan Blackman (Leeds Teaching Hospitals NHS Trust, Leeds, UK). “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.”
“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.”
In native aortic valves, Evolut TAVI systems are currently indicated for implantation in symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the European Union and the USA.
