Nyra Medical has enrolled the first patient in the ENHANCE Early Feasibility Study evaluating its investigational CARLEN System for functional mitral regurgitation.

The study marks the next stage of Nyra’s global clinical programme after encouraging first-in-human experience. The ENHANCE study will evaluate the safety, feasibility and procedural performance of the CARLEN System in patients with symptomatic functional mitral regurgitation.

The CARLEN System is designed as a transcatheter mitral repair platform that augments the native mitral leaflet without sutures, tethers or permanent alteration of valve anatomy. The aim is to restore leaflet coaptation while preserving physiologic leaflet motion and keeping future treatment options open.

This differentiation matters because many structural heart interventions must balance immediate valve repair with long-term anatomical flexibility. In functional mitral regurgitation, repair strategies that preserve valve motion and avoid excessive anatomical disruption may be important for selected patients.

The ENHANCE Early Feasibility Study is a prospective, multicentre, single-arm study. It is being conducted at leading structural heart centres in the United States and Brazil, with safety, performance and clinical endpoints followed for up to five years.

The first enrolment was performed in Brazil at InCor, University of São Paulo Hospital. UC Davis Health is participating as the first U.S. centre in the study. The involvement of structural heart programmes across both countries gives the company a broader evidence-generation pathway across different clinical settings.

The device remains investigational and is not commercially approved. The early feasibility study is intended to support clinical evidence generation and inform future regulatory and commercial milestones.