- In May 2025, Abbott received U.S. FDA approval for its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system, marking a pivotal advancement in structural heart therapies. As the first mitral valve replacement system approved for patients not eligible for open-heart surgery, Tendyne represents a transformative solution for those with severe mitral regurgitation. This development solidifies Abbott’s leading role in the transcatheter valve space while expanding minimally invasive treatment options globally
- In May 2025, Edwards Lifesciences gained FDA approval for its SAPIEN 3 transcatheter aortic valve platform to treat asymptomatic severe aortic stenosis patients. This decision, grounded in the successful EARLY TAVR trial, extends access to life-saving treatment earlier in disease progression. It reflects the growing clinical acceptance of TAVR procedures as a proactive intervention, advancing Edwards’ position as a key innovator in the cardiac valve domain
- In April 2025, UPMC Heart & Vascular Institute became the first center in Pennsylvania to perform a valve-in-valve TAVR procedure using the FDA-approved ShortCut device. This tool enhances procedural safety by modifying calcified leaflets to allow for better access. The milestone showcases progress in reintervention strategies, especially for patients with prior valve replacements, reinforcing the evolution of structural heart techniques
- In March 2025, Medtronic released five-year clinical data from its Evolut TAVR platform, demonstrating sustained durability and positive outcomes in low-risk aortic stenosis patients. The findings confirm the long-term viability of transcatheter valves, supporting broader adoption across patient profiles. This bolsters Medtronic’s global leadership in next-generation heart valve innovation and long-term valve performance.
- In March 2025, early clinical results from the Trilogy transcatheter valve platform showed promise for patients with aortic regurgitation. The device, designed for transcatheter mitral and aortic valve replacement, is gaining attention for its versatility and safety profile. This underlines the momentum behind next-gen devices that can address broader clinical indications in the cardiac valve market
