InnovHeart Achieves Milestone with First U.S. Saturn Transseptal TMVR Implanting 15 Patients Worldwide

InnovHeart's Landmark Achievement in Cardiovascular Technology

InnovHeart has recently celebrated a significant milestone in the world of cardiac treatment. The medical device company has successfully implanted its Saturn Transseptal Transcatheter Mitral Valve Replacement (TMVR) System in the first U.S. patient as part of the CASSINI-US Early Feasibility Study. This pivotal operation took place at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City on August 25, 2026. The procedure was led by Dr. Torsten P. Vahl, a co-director at the Structural Heart and Valve Center.

The patient involved in this groundbreaking study is an 86-year-old woman suffering from severe functional mitral regurgitation. Using a sophisticated percutaneous transseptal approach, the Saturn valve was expertly delivered and implanted in her native mitral valve position. Remarkably, the patient exhibited no issues during the procedure and achieved excellent hemodynamic outcomes, effectively eliminating all signs of mitral regurgitation.

Dr. Vahl expressed enthusiasm about the Saturn implantation in the U.S., emphasizing the importance of this event not just for InnovHeart, but for the advancement of transcatheter mitral valve technologies. The Saturn TMVR System has been designed with several innovative features aimed at overcoming persistent challenges in the TMVR landscape, including anatomical variability and potential left ventricular outflow tract (LVOT) obstruction.

This successful U.S. implantation marks an exciting expansion of InnovHeart's clinical development endeavors following extensive clinical experience gathered through the CASSINI-EU study in Europe. With the latest procedural success, InnovHeart has treated a total of 15 patients globally within the CASSINI clinical program, which includes the patients from the European study.

Long-term follow-up data from the early subjects in the U.S. report exceedingly positive results, with no indications of procedural mortality, zero cases of LVOT obstruction, and the remarkable reduction of mitral regurgitation to at least mild levels in every patient implanted thus far. Overall, hemodynamic stability has been well-documented over time, lending further credibility to the Saturn platform's effectiveness.

David J. Wilson, the Chief Executive Officer of InnovHeart, described the first U.S. implantation as a pivotal moment for both InnovHeart and the Saturn program. He articulated that reaching the milestone of 15 patients worldwide, with follow-up data extending beyond two years, enhances their confidence in the Saturn system's capacity to fulfill unaddressed clinical needs. Additionally, this landmark achievement lays a strong foundation for establishing a clinical presence within the United States and pushes forward their developmental program towards forthcoming stages.

Paolo Denti, MD, who oversees the CASSINI-EU study, noted the encouraging consistency in clinical experiences surrounding the Saturn TMVR System, highlighting sustained valve performance with mild mitral regurgitation, lack of procedural mortality, and stable patient outcomes after two years. This level of reliability in transseptal mitral valve replacement is a significant attribute of the Saturn platform, with the American expansion being a crucial advancement for the entire program.

The overarching goal of the CASSINI clinical initiative is to evaluate the technical feasibility, safety, and performance of the Saturn Transseptal TMVR System in patients enduring moderate to severe symptomatic mitral regurgitation who qualify as candidates for this innovative intervention.

About InnovHeart

InnovHeart specializes in developing advanced medical devices aimed at offering healing solutions to individuals grappling with moderate to severe or severe mitral regurgitation in need of valve replacement. The proprietary Saturn TMVR System is engineered to eradicate mitral regurgitation and restore the functionality of heart valves. As a privately held company with roots in Colleretto Giacosa, Italy, and Newton, Massachusetts, USA, InnovHeart showcases its commitment to innovation and advancement in medical technology. For more information, you can explore their official website at www.InnovHeart.com and follow them on LinkedIn and X (@InnovHeart).

Important Note:

The Saturn Transcatheter Mitral Valve Replacement (TMVR) System is only available for investigational use and is not commercially accessible in any country.