September 24, 2020
InnovHeart Announces First-In-Human Implantation of Saturn TMVR System and 30-Day Results
September 24, 2020–InnovHeart s.r.l. announced the successful first-in-human implantation of the company’s Saturn transcatheter mitral valve replacement (TMVR) system, which demonstrated excellent results in the first patient at 30-day follow-up. The Saturn TMVR system is currently limited to investigational use and not commercially available.
In this first clinical use of the low-profile Saturn, the mitral heart valve was successfully implanted transapically in a 72-year-old man with severe functional mitral regurgitation (MR). The TMVR procedure was performed by the heart team at Santaros Klinikos University Hospital in Vilnius, Lithuania, as part of an ongoing European clinical trial.
Audrius Aidietis, MD, Head of Interventional Cardiology at Santaros Klinikos, noted that at 30 days, the patient had noticeable symptom reduction, improvement in 6-minute walk test and Kansas City Cardiomyopathy Questionnaire quality-of-life survey, and reduction in New York Heart Association classification from III to II. The Saturn valve also exhibited good hemodynamic performance and no MR or outflow tract obstruction.
Dr. Aidietis commented in the company's press release, “The Saturn implant is unique in the way it combines a transcatheter bioprosthetic valve with an annular structure to remodel the native annulus and seal the perimeter of the implant, thus eliminating MR and restoring optimal valve function.”
“The initial clinical experience has been very encouraging and confirms the unique benefits the Saturn TMVR system can offer in terms of annular support, left ventricular outflow tract preservation, sealing capability, and procedural predictability,” added InnovHeart Chief Executive Officer Brent Ratz. “We look forward to providing similar comprehensive treatment for many other patients with MR in the future. Continued enrollment in our European transapical pilot study will provide valuable follow-up data and support for the ongoing development of our transseptal delivery system, which utilizes the same Saturn implant.”