An Italian-developed cardiovascular technology has reached an important milestone in the United States, strengthening a medical and scientific bridge between Italy and America. InnovHeart has announced the first U.S. implantation of its Saturn Transseptal Transcatheter Mitral Valve Replacement system, bringing the total number of patients treated through its CASSINI clinical program to 15 worldwide.
The procedure was performed on August 25 at NewYork-Presbyterian/Columbia University Irving Medical Center in New York. The patient, an 86-year-old woman suffering from severe symptomatic mitral regurgitation, received the Saturn valve through a minimally invasive transseptal procedure. According to the company, the implantation produced an excellent hemodynamic result and eliminated the mitral regurgitation.
The milestone has a particularly strong Italy–U.S. dimension. InnovHeart was founded in 2015 by Italian cardiovascular technology veteran Giovanni Righini and today operates on both sides of the Atlantic, with locations in Italy and Massachusetts. The Saturn program combines Italian medical engineering and European clinical experience with the research capabilities of leading American cardiovascular centers.
The first U.S. procedure follows experience accumulated through the CASSINI-EU study. Among implanted patients evaluated to date, InnovHeart reports no procedural mortality, no left ventricular outflow tract obstruction and mitral regurgitation reduced to mild or less in 100% of cases. Follow-up for the earliest European patients now extends beyond two years.
The American phase significantly expands that transatlantic collaboration. CASSINI-US is designed as a prospective, multicenter early feasibility study involving up to 15 patients at as many as 5 U.S. sites, with participants followed for up to 5 years.
For Italian medical technology, the New York procedure represents more than a clinical milestone. It illustrates how innovation conceived and developed through Italian expertise can enter the U.S. research ecosystem, combining European experience with American clinical excellence. Saturn remains an investigational device and is not commercially available, but its progress provides another concrete example of Italy and the United States working together at the frontier of cardiovascular medicine.
