World’s most populous country gains access to Medtronic’s newest TAVR valve
Medtronic has officially launched its supra-annular, self-expanding Evolut FX+ transcatheter aortic valve replacement (TAVR) system in India. The country’s Central Drugs Standard Control Organization approved the technology in June for the treatment of patients with severe aortic stenosis.
India’s population is believed to be approximately 1.4 billion as of 2023. This includes more than 44.2 million men and more than 48.7 million women 65 years or older, according to one estimate.
Medtronic developed the Evolut FX+ TAVR system with improved coronary access in mind. Its coronary access windows are significantly larger than previous Evolut valves, improving the potential for catheter maneuverability if the patient requires future coronary interventions following treatment. Interventional cardiologists are focused on the lifetime management of patients now more than ever due to the increased use of TAVR among younger patients. If a TAVR patient goes on to require immediate treatment due to a myocardial infarction or other adverse health event later in life, coronary access becomes a critical detail.
“The launch of Evolut FX+ in India marks a meaningful step forward in transcatheter valve therapy,” Prateek Tiwari, senior director of neuroscience and specialty therapies at Medtronic, said in a statement. “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.”
The Evolut FX+ TAVR system gained U.S. Food and Drug Administration (FDA) approval in March 2024 and CE mark approval in October 2024. Both the FDA approval and the CE mark approval included the treatment of low-, intermediate-, high- and extreme-risk TAVR candidates with symptomatic severe aortic stenosis.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.