Nyra Medical announced that it began the first-in-human clinical study evaluating its novel cardiac leaflet enhancer (CARLEN) system.
The study evaluates CARLEN in patients with functional (secondary) mitral regurgitation (FMR). Atlanta-based Nyra says its study already enrolled more than 10 patients, with many having at least a 30-day follow-up.
Nyra Medical designed its proprietary transcatheter technology to repair FMR by augmenting the native mitral valve. CARLEN, a single-leaflet implant, aims to restore coaptation while preserving the valve’s natural motion and orifice area. It has the ability to implant on either the anterior or posterior leaflets, bringing broad clinical applicability and minimal anatomical or clinical exclusions, according to a news release.
CARLEN’s implantation procedure utilizes familiar echocardiographic guidance and intraprocedural imaging, the company says. It supports precise positioning and real-time assessment of valve function.
The company says its versatile design could address the anatomical and functional challenges that limited earlier therapies’ successes. Other companies are also developing innovative leaflet modification devices that center around coaptation, such as CroíValve and Pi-Cardia.
Nyra says it expects enrollment to broaden over the coming months. Data will inform its global regulatory strategy, including engagement with the FDA and other regulatory bodies. The company plans to share early analysis from the study next week at TCT in San Francisco.
“Achieving first-in-human data is a major milestone event for any medtech company,” said Lori Chmura, CEO of Nyra Medical. “Nyra’s early clinical results underscore the potential of this platform to redefine how we treat structural heart disease.”
