InnovHeart Announces First-In-Human Trans-Septal Implantation of Saturn Mitral Valve Replacement

NEWTON, Mass. and MILAN, May 30, 2024 /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 first trans-septal clinical trial implant with the proprietary Saturn Transcatheter Mitral Valve. Excellent hemodynamic results are reported for the patient, a 79 year old female suffering from severe mixed (degenerative and functional) mitral regurgitation. The Trans-Septal TMVR procedure was performed as part of the on-going European clinical trial, the CASSINI-EU study, on May 8^th, 2024 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD¹; Giedrius Davidavičius, MD¹; Agnė Drąsutienė, MD¹; Vilhelmas Bajoras, MD¹; supported by Torsten Vahl, MD²; Lauren Ranard, MD²; Paolo Denti, MD³; and Stefano Stella, MD³.

"We were honored to work with this outstanding international team providing life-changing novel TMVR therapy for this high surgical-risk patient. It is particularly rewarding to support the InnovHeart progression from trans-apical to trans-septal delivery of the Saturn Valve at our Institute," said Dr. Giedrius Davidavičius. "This first case is a critical step to validate that the Saturn valve can be successfully delivered via a fully percutaneous, transfemoral transseptal approach. The Saturn prosthesis has a unique modular design comprising an annular ring and low-profile valve that can reverse remodel the native annulus, avoid LVOT obstruction and eliminate MR" said Dr. Torsten Vahl.  

"Overall, this important case demonstrates that the Saturn valve can be successfully implanted with either retrograde or antegrade approaches. It is exciting to add trans-septal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial trans-apical study, now in long-term follow-up. I continue to believe that Saturn will become a valuable new therapy with fewer anatomical exclusions than other technologies, with the potential to treat a wider range of patients," said Dr. Paolo Denti who is the Principal Investigator for the CASSINI-EU study. "We are very grateful for the skilled physicians who successfully completed our first trans-septal CASSINI study case and for our Founder and CTO, Giovanni Righini, for realizing this very important milestone for patients and the company," said David Wilson, InnovHeart CEO. The CASSINI-EU study will expand to multiple countries and enroll up to 30 patients with moderate to severe or severe MR.

1 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
2 Structural Heart and Valve Center, New York-Presbyterian Hospital, Columbia University Irving Medical Center, New York, USA 
3 San Raffaele University Hospital, Milano, Italy

About InnovHeart

InnovHeart is a medical device company dedicated to providing new treatment options for people suffering from moderate to severe or severe mitral regurgitation (MR) and who need a mitral valve replacement. The InnovHeart proprietary Saturn Transcatheter Mitral Valve Replacement (TMVR) System is designed to eliminate mitral regurgitation and restore normal valve function. InnovHeart is a privately held company located in Colleretto Giacosa, Italy and Newton, Mass, USA. For more information, please visit www.InnovHeart.com and follow us on LinkedIn and X (@InnovHeart).

Caution: The SATURN Transcatheter Mitral Valve Replacement (TMVR) System is limited to investigational use and is not commercially available in any country.

SOURCE InnovHeart