Nyra Medical has enrolled the first patient in its ENHANCE early feasibility study evaluating the investigational CARLEN transcatheter cardiac leaflet enhancer for patients with functional mitral regurgitation (FMR).
CARLEN is a single-leaflet implant designed to augment the native mitral valve, restoring leaflet coaptation while preserving natural valve motion and orifice area. The device can be implanted on either the anterior or posterior leaflet and uses familiar echocardiographic guidance for positioning and real-time assessment of valve function.
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The U.S. and Brazil-based study will evaluate the safety, feasibility and procedural performance of CARLEN, with patient follow-up planned for up to five years. The trial follows encouraging first-in-human clinical experience and aims to generate evidence supporting future regulatory and commercial milestones.
CEO Lori Chmura said:
“This enrollment represents more than the beginning of another clinical study. It reflects the steady execution of our long-term strategy to redefine transcatheter mitral valve repair.”
The milestone advances Nyra Medical’s efforts to develop a less invasive treatment option for patients with symptomatic FMR, a condition with significant unmet clinical needs.
