NEWTON, Mass. — InnovHeart said it has completed the first U.S. implantation of its Saturn Transseptal Transcatheter Mitral Valve Replacement system as part of the CASSINI-US Early Feasibility Study.
The procedure was performed Aug. 25 at NewYork-Presbyterian/Columbia University Irving Medical Center in New York by Principal Investigator Torsten P. Vahl, M.D., Co-Director of the Structural Heart and Valve Center.
The patient was an 86-year-old woman with severe symptomatic mitral regurgitation. InnovHeart said the Saturn valve was delivered through a percutaneous transseptal approach and implanted in the native mitral valve position.
The company said the patient tolerated the procedure well and had an elimination of mitral regurgitation following implantation.
“Performing the first Saturn implantation in the United States is an important milestone for our team and for the development of transcatheter mitral valve replacement,” Vahl said. “The Saturn system has unique features designed to address several of the challenges that have historically limited TMVR, including anatomical variability and the risk of LVOT obstruction.”
The U.S. procedure expands InnovHeart’s clinical development program beyond Europe, where the Saturn system has been evaluated through the CASSINI-EU study.
With the latest procedure, 15 patients have now been treated globally across the CASSINI clinical program.
InnovHeart said follow-up of the earliest European patients now exceeds two years. Across the clinical experience to date, the company reported no procedural mortality or left ventricular outflow tract obstruction, while mitral regurgitation was reduced to mild or less in all implanted patients.
“Including the first U.S. patient implantation is a defining moment for InnovHeart and for the Saturn program,” said David J. Wilson, Chief Executive Officer of InnovHeart. “Reaching 15 patients globally, with follow-up extending to two years, gives us increasing confidence in Saturn’s ability to address the unmet clinical needs of patients.”
The CASSINI clinical program is evaluating the technical feasibility, safety and performance of the Saturn system in patients with moderate-to-severe or severe symptomatic mitral regurgitation who are candidates for transcatheter mitral valve replacement.
