New Delhi, September 9, 2025:

Medtronic, a global leader in healthcare technology, launched its new transcatheter aortic valve, Evolut™ FX+, in India. The valve is designed to help improve treatment for patients with severe aortic stenosis, especially those who may need future coronary procedures. The Evolut FX+ TAVI system facilitates easier coronary access while maintaining the proven performance of the Evolut™ platform, based on CoreValve™ technology. It was approved by the Central Drugs Standard Control Organization (CDSCO) on June 10, 2025, paving the way for its launch in India. ¹

The main innovation of Evolut FX+ is its new frame with bigger windows to reduce frame interference while using guide catheters, especially during complex coronary procedures. The system continues to deliver the key advantages that clinicians have come to expect from previous Evolut valves. The system provides market leading valve performance including durable low gradients, which are important for long-term heart function. This makes it a strong alternative for patients at risk of coronary disease while supporting long-term treatment needs. ^2&3

The introduction of Evolut FX+ in India marks a significant advancement in transcatheter aortic valve therapy and reinforces Medtronic’s leadership in structural heart innovation. With enhanced coronary access and proven hemodynamic performance, the Evolut FX+ empowers physicians to deliver both immediate procedural success and sustained long-term care.  This milestone underscores Medtronic’s steadfast dedication to broadening access to advanced therapies and driving innovation in cardiovascular care and treatment across India.

Commenting on the product launch by Medtronic, Prateek Tiwari, Senior Director Neuroscience & Speciality Therapies, Medtronic said, “The launch of Evolut FX+ in India marks a meaningful step forward in transcatheter valve therapy. With its enhanced coronary access and proven hemodynamic performance, FX+ empowers physicians to deliver confident care—not just during the initial procedure, but throughout the patient’s lifetime. By bringing this innovation to India, we are advancing Medtronic’s mission to alleviate pain, restore health, and extend life, while expanding access to future-ready solutions for structural heart disease.”

Evolut FX+ keeps the same tissue structure, valve design, and inflow strength as earlier models, ensuring consistency and reliability. For heart teams, FX+ provides a modern solution that simplifies future coronary treatments, increases patient access to TAVR, and maintains familiar clinical practices. With this launch, Medtronic reinforces its commitment to expanding patient access to innovative therapies, helping more patients benefit from advanced treatment options for structural heart disease. ⁴

For further information, please contact:

Medtronic

Masooma Pathre

masooma.pathre@medtronic.com

About Medtronic 

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn. 

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. All details contained in this release are for general awareness purposes only and do not constitute medical advice. 

1. Based on Evolut™ FX+ Test Reports: D01073856, D01095344, D01084996. Medtronic data on file. Performance as compared to Evolut™ PRO+ and FX system in bench testing.
2. Based on Evolut™ FX+ Test Report: DO1106198 Rev. A. Medtronic computational data model on file compared to the Evolut™ platform.
3. Evolut FX+ Test Reports: D01073856, D01095344, D01084996.
4. Evolut FX+ Test Report: DO1106198 Rev. A.