Nyra Medical offers the Cardiac Leaflet Enhancer (CARLEN), a transcatheter, single‑leaflet nitinol clip that augments the length and thickness of the mitral valve leaflets to treat functional (secondary) mitral regurgitation. Delivered via a transfemoral, transseptal approach under imaging guidance, CARLEN preserves native valve geometry, is reversible, and expands treatment eligibility for patients who are ineligible for existing edge‑to‑edge repair systems.
Funding
$20M 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.
2OFounders
Product
Problem
Functional (secondary) mitral regurgitation (FMR) affects many heart‑failure patients who cannot undergo surgery and are ineligible for existing transcatheter edge‑to‑edge repair (TEER) systems due to anatomical constraints. Current devices often restrict leaflet motion, alter valve geometry, and may preclude future interventions, leaving a large patient cohort without effective treatment options.
Solution
Nyra Medical has developed the Cardiac Leaflet Enhancer (CARLEN), a transcatheter, single‑leaflet implant that augments the native mitral valve leaflets rather than approximating them. Delivered via a transfemoral, transseptal approach under real‑time imaging, CARLEN clips onto either the anterior or posterior leaflet, adding length and thickness at the regurgitant site to restore coaptation while preserving the valve’s natural orifice and flow dynamics. The sutureless nitinol attachment is atraumatic and reversible, allowing precise positioning and the possibility of future surgical or transcatheter procedures. By expanding eligibility beyond TEER‑suitable anatomies, CARLEN aims to provide a minimally invasive repair option for patients previously excluded from transcatheter therapy.
Target Audience
Primary customers are interventional cardiologists and heart‑failure teams at hospitals and specialty cardiac centers that treat patients with functional mitral regurgitation, especially those unsuitable for current TEER devices.
Features
- Single‑leaflet nitinol clip that adds length and thickness to the targeted mitral leaflet
- Sutureless, reversible attachment mechanism that preserves native tissue and enables repositioning
- Transfemoral, transseptal delivery system compatible with existing imaging workflows
- Maintains diastolic orifice area and physiological flow, minimizing risk of mitral stenosis
- Forward‑compatible design that does not interfere with subsequent surgical or transcatheter valve interventions
- Intuitive catheter handling with a short learning curve, supported by >70 nonclinical studies and first‑in‑human success