InnovHeart has announced the first transseptal 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 company announced in a press release.
The transseptal transcatheter mitral valve replacement (TMVR) procedure was performed as part of the ongoing European clinical trial, CASSINI-EU, at Santaros Klinikos University Hospital (Vilnius, Lithuania) with the heart team of Kęstutis Ručinskas, Giedrius Davidavičius, Agnė Drąsutienė, Vilhelmas Bajoras, supported by Torsten Vahl, Lauren Ranard, Paolo Denti, and Stefano Stella.
“We were honoured 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 transapical to transseptal delivery of the Saturn Valve at our Institute,” said 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 [left ventricular outflow tract] obstruction and eliminate MR,” said 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 transseptal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial transapical 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 Denti who is the principal investigator for the CASSINI-EU study.
“We are very grateful for the skilled physicians who successfully completed our first transseptal CASSINI study case and for our founder and CTO, Giovanni Righini, for realising this very important milestone for patients and the company,” said David Wilson, InnovHeart CEO.
The CASSINI-EU study will expand to multiple countries and enrol up to 30 patients with moderate to severe or severe MR.
