InnovHeart has announced the successful implantation of the first US patient with the Saturn transcatheter mitral valve replacement (TMVR) system as part of the CASSINI-US early feasibility study.
The procedure was performed at NewYork-Presbyterian/Columbia University Irving Medical Center (New York, USA) by principal investigator, Torsten P Vahl. The patient was an 86-year-old female with functional symptomatic severe (4+) mitral regurgitation (MR). The medical team included Lauren S Ranard, Isaac George, and Rebecca T Hahn of NewYork-Presbyterian and Columbia.
The Saturn valve was successfully delivered through a percutaneous, transseptal approach, with the device implanted in the native mitral valve position. The patient tolerated the procedure well with an excellent haemodynamic result and elimination of MR, the company says in a press release.
“Performing the first Saturn implantation in the USA is an important milestone for our team and for the development of transcatheter mitral valve replacement,” said Vahl. “The Saturn system has unique features designed to address several of the challenges that have historically limited TMVR, including anatomical variability and the risk of LVOT obstruction. We look forward to continuing the clinical evaluation of this technology in the CASSINI-US study.”
The first US implantation marks the expansion of the InnovHeart clinical development program into the USA following the clinical experience accumulated in Europe through the CASSINI-EU study.
With the first US procedure, InnovHeart says it has now reached 15 patients treated globally across the CASSINI clinical programme, including patients treated in the CASSINI-EU study.
Clinical follow-up of the early EU subjects exceeds two years, with encouraging results observed across the clinical experience to date, the company states, including no procedural mortality, no left ventricular outflow tract (LVOT) obstruction and reduction of MR to ≤ mild in 100% of implanted patients. Haemodynamics have been stable with time.
“Including the first US patient implantation is a defining moment for InnovHeart and for the Saturn programme,” said David J Wilson, CEO of InnovHeart. “Reaching 15 patients globally, with follow-up extending to two years, gives us increasing confidence in Saturn’s ability to address the unmet clinical needs of patients. This milestone also represents an important step toward establishing a clinical presence in the USA and advancing our development programme towards the next stage.”
Paolo Denti (San Raffaele Hospital, Milan, Italy), principal investigator of the CASSINI-EU study, added: “What is particularly encouraging is the consistency of the clinical experience. We have observed MR ≤ mild, no LVOT obstruction, no procedural mortality, and sustained valve performance in patients followed for up to two years. The ability to achieve consistent transseptal mitral valve replacement is an important feature of the Saturn platform, and the expansion into the USA represents a significant next step for the programme.”
The CASSINI clinical programme is designed to evaluate the technical feasibility, safety, and performance of the Saturn transseptal TMVR System in patients with moderate-severe or severe symptomatic MR who are candidates for TMVR.
