Nyra Medical has commenced a clinical trial to test its new Cardiac Leaflet Enhancer (CARLEN) system in individuals with functional mitral regurgitation (FMR).
The first-in-human trial is aimed at evaluating the technical performance and safety of the device, with more than ten subjects already participating and several having completed a follow-up period of at least 30 days.
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According to the company, the transcatheter technology is tailored to rectify FMR by enhancing the native mitral valve’s function.
The single-leaflet implant works by restoring leaflet coaptation while maintaining the valve’s natural movement and orifice space.
It can be implanted on either the posterior or anterior leaflets and offers a wide range of clinical applications with few anatomical or clinical restrictions.
The implantation process for the CARLEN system utilises echocardiographic guidance as well as imaging during the procedure to ensure proper placement and monitor valve function in real-time.
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By GlobalDataThe trial is taking place at medical centres in Paraguay, Uzbekistan, and the Republic of Georgia.
US physicians Montefiore Medical Center Interventional Cardiology and Structural Heart director Dr Azeem Latib, New York Presbyterian Medical Center Structural Heart & Valve Center director Dr Susheel Kodali, and Montefiore Medical Center structural heart imaging director Dr Edwin Ho are supporting the trial.
The early clinical data will be essential for refining the procedure and device performance, paving the way for broader clinical research.
The outcomes of this initial study will inform Nyra Medical’s strategy for regulatory approval, including its engagement with the US Food and Drug Administration (FDA) and other regulatory entities.
These insights will also influence the planning of subsequent clinical trials, which may include an early feasibility study as well as a pivotal US trial.
Dr Ho said: “For interventional echocardiographers, CARLEN introduces innovation without adding complexity.
“By maintaining the familiar imaging workflow, we can focus on optimising outcomes with confidence as we visualise leaflet engagement and function with remarkable clarity.”
