Clinical Accelerator, a clinical trial management organization specializing in the cardiovascular field, is pleased to announce its collaboration with Nyra Medical on the clinical evaluation of the CArdiac Leaflet ENhancer (CARLEN) System, a novel transcatheter heart valve repair technology designed to address functional mitral valve regurgitation. The study is set to take place at THVC (Tbilisi Heart and Vascular Centre) and Healthycore (Israeli-Georgian Medical Center) in Tbilisi, Georgia, two renowned centers for clinical trials with innovative cardiac devices.
The CARLEN System, developed by Nyra Medical, offers a transcatheter solution for patients suffering from functional mitral regurgitation. Using a transcatheter femoral venous approach, the CARLEN System is designed to restore normal mitral valve function by augmenting the native valve’s leaflet with an implant, restoring coaptation and correcting regurgitation. As it preserves the native valve geometry, CARLEN is designed to be the first forward compatible device that allows future interventions.
Functional mitral regurgitation (FMR), often caused by ventricular or atrial dysfunction, presents a significant challenge as it increases mortality, heart failure hospitalizations and reduces patients quality of life. There is a significant unment clinical need for therapies that would effectively treat the valve lesion, without too many anatomical exclusion criteria or sacrificing the native valve geometry. The CARLEN System addresses this gap and is designed to improve outcomes and expand transcatheter FMR therapies to a broader patient population.
“This collaboration with Nyra Medical brings an exciting new solution to the forefront of mitral valve repair,” said Dr. Nik Nikitin, Managing Director at Clinical Accelerator. “The CARLEN System’s innovative approach to valve enhancement has the potential to address a long-standing unmet need in cardiology by providing an alternative to high-risk surgical procedures. We are confident that the study at THVC and Healthycore will help validate this technology and obtain valuable early clinical data which will accelerate its further development
Unlike existing transcatheter devices which rely on approximating valve leaflets to reduce regurgitation, the CARLEN System focuses on enhancing leaflet dimensions to restore the valve’s natural function. This approach minimizes the risk of complications such as elevated transvalvular gradients or restricted diastolic inflow, which can adversely impact outcomes in other systems.
“The study at two Georgian sites will evaluate the safety and feasibility of the CARLEN System in treating patients with moderate or greater functional mitral valve regurgitation. The expertise of the investigative team at THVC and Healthycore, combined with the innovative design of the CARLEN System, aims to push the boundaries of what is possible in transcatheter mitral valve repair,” said Lori Chmura, CEO of Nyra Medical
About Clinical Accelerator
Clinical Accelerator is an independent clinical trial management organization specializing in the acceleration of medical device development through early-stage and feasibility studies. The company’s expertise allows it to facilitate the rapid and effective implementation of innovative technologies across diverse therapeutic areas.
About Nyra Medical
Nyra Medical is a pioneering medtech company committed to developing minimally invasive therapies for structural heart diseases. Its flagship CARLEN System is designed to provide a novel solution for patients with functional mitral valve regurgitation, combining innovation with a patient-centric approach to improve outcomes and expand access to life-saving treatments.