First U.S. Patient Implanted with InnovHeart's Saturn TMVR System

InnovHeart, a medical device company based in Newton, Massachusetts, and Colleretto Giacosa, Italy, has reached a significant milestone with the successful implantation of its Saturn Transseptal Transcatheter Mitral Valve Replacement (TMVR) System in the United States. This marks the first U.S. patient to receive the system, bringing the total number of patients treated globally to 15.

The procedure was conducted on August 25th at NewYork-Presbyterian/Columbia University Irving Medical Center in New York. The patient, an 86-year-old female with severe mitral regurgitation, underwent the transseptal approach procedure under the guidance of Principal Investigator Dr. Torsten P. Vahl, an assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. Dr. Vahl was joined by a team of medical professionals, including Dr. Lauren S. Ranard, Dr. Isaac George, and Dr. Rebecca T. Hahn, all from NewYork-Presbyterian and Columbia University.

"The first U.S. implantation of the Saturn system is a critical step in our clinical development," said Dr. Vahl. "The Saturn valve addresses several challenges in TMVR, including anatomical variability and the risk of left ventricular outflow tract (LVOT) obstruction. We are excited to continue evaluating this technology in the CASSINI-US study."

The Saturn TMVR System was successfully delivered and implanted in the patient's native mitral valve position. Post-procedure, the patient demonstrated excellent hemodynamic results and complete elimination of mitral regurgitation. Dr. Vahl, who also receives consulting payments from InnovHeart, stated that the patient's successful outcome aligns with the encouraging results observed in earlier clinical experiences.

The first U.S. implantation follows the company's successful experience in Europe, where the CASSINI-EU study has treated 10 patients. Clinical follow-up of these patients, extending to two years, has yielded positive results, with no procedural mortality, no LVOT obstruction, and a 100% reduction in mitral regurgitation to ≤ mild.

"Reaching 15 patients treated globally, including the first U.S. patient, is a defining moment for InnovHeart," said David J. Wilson, CEO of InnovHeart. "This milestone provides us with increasing confidence in the Saturn system's ability to address unmet clinical needs. It also represents a significant step towards establishing a clinical presence in the United States."

Paolo Denti, MD, the Principal Investigator of the CASSINI-EU study, echoed Dr. Vahl's sentiments. "The consistency of the clinical experience is particularly encouraging. We have observed a reduction in mitral regurgitation to ≤ mild, no LVOT obstruction, and no procedural mortality in patients followed for up to two years. The Saturn platform's ability to achieve consistent transseptal mitral valve replacement is a significant advancement."

The CASSINI clinical program, which includes both the U.S. and European studies, is designed to assess the technical feasibility, safety, and performance of the Saturn Transseptal TMVR System in patients with moderate to severe symptomatic mitral regurgitation. InnovHeart continues to move forward with its development program, aiming to bring its innovative treatment options to a broader patient population.