Sam Brusco, Associate Editor05.30.24
InnovHeart, a developer of novel transcatheter mitral valve replacement (TMVR) systems has achieved its first transseptal clinical trial implant with its Saturn transcatheter mitral valve.
The procedure was done as part of the ongoing European CASSINI-EU trial on May 8 at Santaros Klinikos University Hospital in Vilnius, Lithuania. The heart team was comprised of Kęstutis Ručinskas, MD; Giedrius Davidavičius, MD; Agnė Drąsutienė, MD; Vilhelmas Bajoras, MD; supported by Torsten Vahl, MD; Lauren Ranard, MD; Paolo Denti, MD; and Stefano Stella, MD.
Dr. Vahl said the first case is a critical step to validating 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 mitral regurgitation (MR)," Dr. Vahl told the press.
Principal CASSINI-EU investigator Dr. Paolo Denti said the case demonstrates 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,” Dr. Denti said. “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."
The CASSINI-EU study will soon expand to multiple countries and enroll up to 30 patients with moderate to severe mitral regurgitation.
"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 procedure was done as part of the ongoing European CASSINI-EU trial on May 8 at Santaros Klinikos University Hospital in Vilnius, Lithuania. The heart team was comprised of Kęstutis Ručinskas, MD; Giedrius Davidavičius, MD; Agnė Drąsutienė, MD; Vilhelmas Bajoras, MD; supported by Torsten Vahl, MD; Lauren Ranard, MD; Paolo Denti, MD; and Stefano Stella, MD.
Dr. Vahl said the first case is a critical step to validating 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 mitral regurgitation (MR)," Dr. Vahl told the press.
Principal CASSINI-EU investigator Dr. Paolo Denti said the case demonstrates 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,” Dr. Denti said. “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."
The CASSINI-EU study will soon expand to multiple countries and enroll up to 30 patients with moderate to severe mitral regurgitation.
"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.