CASSINI-US Early Feasibility Study Begins for InnovHeart’s Saturn Transseptal TMVR System

September 14, 2026—InnovHeart announced the first United States implantation of the company’s Saturn transseptal transcatheter mitral valve replacement (TMVR) system.

The company stated that the procedure marks the first patient enrollment in the CASSINI-US early feasibility study, which expands InnovHeart ’s CASSINI clinical program into the United States after the clinical experience accumulated in Europe through the CASSINI-EU study.

The CASSINI program, which has now treated 15 patients globally, is designed to evaluate the technical feasibility, safety, and performance of the Saturn system in patients with moderate-severe or severe symptomatic mitral regurgitation (MR) who are candidates for TMVR, advised InnovHeart.

The procedure was performed by CASSINI-US Principal Investigator Torsten P. Vahl, MD, at NewYork-Presbyterian/Columbia University Irving Medical Center in New York, New York.

“Performing the first Saturn implantation in the United States is an important milestone for our team and for the development of TMVR,” commented Dr. Vahl in the InnovHeart press release. “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 left ventricular outflow tract (LVOT) obstruction. We look forward to continuing the clinical evaluation of this technology in the CASSINI-US study.”

InnovHeart advised that clinical follow-up of the early patients enrolled in Europe now exceeds 2 years with findings showing no procedural mortality, no LVOT, and a reduction of MR to mild or less in 100% of implanted patients. Hemodynamics have been stable with time, noted the press release.

Paolo Denti, MD, who is Principal Investigator of the CASSINI-EU study, stated in the press release, “What is particularly encouraging is the consistency of the clinical experience. We have observed MR ≤ mild, no LVOT obstruction, no procedural mortality, and sustained valve performance in patients followed for up to 2 years. The ability to achieve consistent transseptal mitral valve replacement is an important feature of the Saturn platform, and the expansion into the United States represents a significant next step for the program.”