InnovHeart has created the Saturn Transcatheter Mitral Valve Replacement (TMVR) system, a fully percutaneous, transfemoral, trans‑septal platform that delivers a self‑expanding mitral valve prosthesis without open‑chest or trans‑apical access. The system enables interventional cardiologists and cardiac surgeons to treat high‑risk patients with severe mitral regurgitation through a minimally invasive, single‑step procedure, reducing hospital stay and procedural complications.
Funding
$55M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
2OCGFounders
Product
Problem
Patients with severe mitral regurgitation often require open‑heart surgery or trans‑apical catheter procedures, which carry high procedural risk, long recovery times, and limited suitability for high‑risk or frail patients.
Solution
InnovHeart has developed the Saturn Transcatheter Mitral Valve Replacement (TMVR) system, a fully percutaneous, transfemoral, trans‑septal platform that delivers a self‑expanding mitral valve prosthesis without the need for thoracotomy or trans‑apical access. The system uses a dedicated delivery catheter and a trans‑septal puncture technique to navigate from the femoral vein to the left atrium, enabling implantation in a single minimally invasive step. Clinical data from the CASSINI EU Early Feasibility Study and first‑in‑human trials demonstrate favorable hemodynamic performance and rapid patient recovery. By eliminating major surgical incisions, the Saturn TMVR expands treatment options for high‑risk mitral valve disease patients and reduces hospital stay and procedural complications.
Target Audience
Primary customers are interventional cardiologists, cardiac surgeons, and hospital heart teams seeking minimally invasive solutions for patients with severe mitral regurgitation who are unsuitable for conventional surgery.
Features
- Trans‑septal, transfemoral delivery eliminates the need for open chest or trans‑apical access
- Self‑expanding nitinol frame with integrated sealing skirt for secure anchoring in the mitral annulus
- Fully percutaneous delivery system with low‑profile catheter compatible with standard femoral venous access
- Real‑time imaging integration and precise positioning controls to ensure optimal valve alignment
- Proven hemodynamic results from early feasibility studies, including low trans‑valvular gradients and minimal paravalvular leak