InnovHeart reports first-in-human implantation of its Saturn Transcatheter Mitral Valve with 30-day follow-up – DOTmed HealthCare Business News

NEWTON, Mass. and MILAN, Sept. 24, 2020 /PRNewswire/ -- InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of Mitral Regurgitation (MR), announced today the successful First-in-Human implantation of its proprietary Saturn Transcatheter Mitral Valve along with excellent results at the 30-day follow-up for the patient, a 72 year old male suffering from severe Functional Mitral Regurgitation. The Trans-Apical TMVR procedure was performed as part of an on-going European clinical trial on August 19, 2020 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kstutis Ruinskas, MD, Audrius Aidietis MD, Vilius Januauskas, MD and Valdas Bilkis, MD supported by Paolo Denti, MD and Stefano Stella, MD.

"We are grateful to have had the opportunity to work with Dr. Denti, Dr. Stella, and the InnovHeart team in order to provide a novel treatment option for this high-risk patient," said Dr.Kstutis Ruinskas, Primary Investigator and Head of Cardiac Surgery at Santaros Klinikos. "Although it was the first clinical use of the Saturn valve, the procedure was straight-forward, and the valve was implanted successfully with excellent function."

"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 mitral regurgitation and restoring optimal valve function," added Dr. Audrius Aidietis, Head of Interventional Cardiology at Santaros Klinikos. "After 30 days, the patient has already experienced a noticeable reduction in symptoms, with improvements in six-minute walk test, KCCQ Quality of Life survey and a reduction from NYHA III to NYHA II. In addition, the valve continues to exhibit outstanding hemodynamic performance with no MR and no outflow tract obstruction."

"The initial clinical experience has been very encouraging and confirms the unique benefits the Saturn TMVR system can offer in terms of annular support, LVOT preservation, sealing capability and procedural predictability. We look forward to providing similar comprehensive treatment for many other patients with MR in the future. Continued enrollment in our European Trans-Apical Pilot Study will provide valuable follow-up data and support for the on-going development of our Trans-Septal delivery system, which utilizes the same Saturn implant," added Brent Ratz, InnovHeart Chief Executive Officer.

About InnovHeart InnovHeart s.r.l, with locations in Milan, Italy, and Newton, Mass., USA, develops Transcatheter Mitral Valve Replacement systems (TMVR) to treat patients suffering from mitral valve disease. The company is conducting clinical trials of its novel Saturn TMVR system. Saturn is a low-profile mitral heart valve designed for trans-apical or trans-septal delivery.

SOURCE InnovHeart

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InnovHeart reports first-in-human implantation of its Saturn Transcatheter Mitral Valve with 30-day follow-up - DOTmed HealthCare Business News