Medtronic's Evolut PRO+ and FX TAVR Systems Receive CE Mark for Redo-TAVR Indication, Enabling Valve-in-Valve Implantation in Any Failed TAV

May 22, 2025 22:15 CST Updated 22:15

Medtronic

Chronic Disease Medical Device and Therapy Developer

Medtronic Announces Its Evolut PRO+ and FX TAVR Products"Second TAVR" Indication Receives CE Approval for Market Launch, Allowing Physicians to Implant a Brand-New Evolut Transcatheter Aortic Valve Within Any Failed Transcatheter Aortic Valve (TAVR).。

The secondary TAVR procedure approved this time is suitable for the following patient groups: patients with severe aortic stenosis and dysfunction of any transcatheter aortic valve manufactured by any producer, as well as patients at high risk for open-chest surgery.

Expert Evaluation

"For clinicians in this field, the CE certification of Evolut TAVR for secondary TAVR indications is undoubtedly a significant positive development. More importantly, it opens up a crucial new treatment pathway for patients with transcatheter heart valve failure. This minimally invasive procedure not only provides an alternative for high-risk surgical patients but also demonstrates the medical community's steadfast commitment to continuously improving treatment outcomes and expanding the reach of TAVR therapy."

---Dan Blackman Leeds Teaching Hospitals

Executive Evaluation

"Indications for Secondary TAVR are based on the time-tested valve performance and durability of the Evolut platform, providing patients with a safe and reliable full-lifecycle management solution. This not only empowers physicians to achieve excellent immediate clinical outcomes but also preserves significant treatment options for the future. The certification underscores Medtronic's relentless efforts to advance global patient care and expand access to therapies."

---Jorie Soskin Vice President and General Manager of the Structural Heart Division under Medtronic's Cardiovascular Business

Currently, Medtronic is in the EU and the US,The Evolut series of TAVR has been approved for use in all risk categories (extremely high-risk, high-risk, intermediate-risk, and low-risk) of symptomatic patients with severe aortic stenosis undergoing native aortic valve (i.e., non-prosthetic valve) implantation. With thisEvolut PRO+ and FX approved for use in China"Secondary TAVR" indications not only involve prosthetic valvesPatients with failure can receive better treatment, while also expandingApplicable Scope of the Evolut Series.

Evolut FX

Medtronic developedEvolut FX, due to the optimization of the insufficient performance of the first three generations of Evolut TAVR.

Evolut FXThe main difference from the previous three generations lies in its improved operability and visibility.

“Evolut FX"The design aims to improve the entire surgical process experience by enhancing and delivering capabilities, implant visibility, and deployment stability."

-----Geoff Martha

Evolut FX has made many changes to the delivery system,Evolut FXThe distal end of the redesigned delivery system, toAchieve a smoother insertion profile, more flexible delivery, allow 360-degree freedom of movement, and have stable, predictable deployment.EvolutFX Delivery SystemImproved adaptability to anatomical structures, reducing tracking force by 50% in challenging anatomical structures. ThusMake the overall TAVR procedure easier to perform and reduce the surgical difficulty.

At the same timeEvolut FXIt also increases catheter support during deployment, thereby reducing ventricular motion by 50%.

In additionEvolut FXThe use of gold as a radiopaque marker in the stent provides doctors with direct visualization of the depth and leaflet position during implantation.

OthersEvolut FX Compared with the first three generations of Evolut TAVRBoth adopt self-expanding nitinol frame designs to adapt to the native annulus with consistent radial force.Advanced sealing. And, like the third-generation Evolut PRO+, it has four different valve sizes, with the 23mm, 26mm, and 29mm valves able to pass through a 5mm vessel, and the 34mm valve able to pass through a 6mm vessel.

Medtronic

Medtronic, plc. is headquartered in Dublin, Ireland, and is one of the largest medical technology, services, and solutions companies in the world — alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company focuses on collaborating with stakeholders around the world to advance healthcare.