We are glad to announce the successful implantation of the first U.S. patient with our Saturn system as part of the CASSINI-US Early Feasibility Study. The procedure was performed on August 25th at NewYork-Presbyterian/Columbia University Irving Medical Center in New York by Principal Investigator, Torsten P. Vahl, MD, co-director of the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Irving Medical Center. The patient was an 86-year-old female with functional symptomatic severe (4+) mitral regurgitation. The medical team included Lauren S. Ranard, MD, Isaac George, MD, and Rebecca T. Hahn, MD, of NewYork-Presbyterian and Columbia.
The Saturn valve was successfully delivered through a percutaneous, transseptal approach, with the device implanted in the native mitral valve position. The patient tolerated the procedure well with an excellent hemodynamic result and elimination of mitral regurgitation.
“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,” said Dr. Vahl, an assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. “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. We look forward to continuing the clinical evaluation of this technology in the CASSINI-US study.” Dr. Vahl discloses consulting payments from InnovHeart.
The first U.S. implantation marks the expansion of the InnovHeart clinical development program into the United States following the clinical experience accumulated in Europe through the CASSINI-EU study.
With the first U.S. procedure, InnovHeart has now reached 15 patients treated globally across the CASSINI clinical program, including patients treated in the CASSINI-EU study.
Clinical follow-up of the early EU subjects exceeds two years, with encouraging results observed across the clinical experience to date, including no procedural mortality, no LVOT obstruction and reduction of mitral regurgitation to ≤ mild in 100% of implanted patients. Hemodynamics have been stable with time.
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