CARLEN: A New Standard in Mitral Valve Repair
The Cardiac Leaflet Enhancer (CARLEN) is Nyra Medical’s investigational medical device, with proprietary transcatheter technology designed to repair functional (secondary) mitral regurgitation (FMR) by augmenting the native mitral valve — not restricting it.
Unlike traditional transcatheter edge-to-edge repair (TEER) systems that approximate both leaflets and alter valve geometry, CARLEN is a single-leaflet implant designed to restore coaptation while preserving the valve’s natural motion and orifice area. CARLEN aims to broaden access to transcatheter repair for both TEER-eligible patients and those previously excluded by anatomical limitations. Capitalizing on existing workflow, the CARLEN System is delivered via a transfemoral, transseptal approach, enabling intuitive, precise leaflet enhancement without sutures, tethers, or permanent deformation.
A Simple, Elegant Solution for a Complex Problem
CARLEN is delivered to either the anterior or posterior leaflet of the mitral valve using real-time imaging guidance. Once deployed, the implant is intended to:
- Clip onto a single leaflet edge using a proprietary, atraumatic nitinol mechanism
- Add length and thickness to the leaflet at the site of regurgitation
- Re-establish valve coaptation, eliminating the regurgitant jet
- Maintain physiological flow throughout the cardiac cycle, minimizing the risk of mitral stenosis
Because CARLEN augments — rather than restricts — native leaflet motion, it’s designed to preserve the diastolic orifice and enable future compatibility with other mitral interventions, including surgical or transcatheter valve interventions.
Key Design Advantages
- Single-Leaflet Repair: Treats broad range of anatomies including both TEER suitable and anatomies not accessible by TEER, including atrial FMR and commissural jets
- Sutureless, Reversible Attachment: Preserves native tissue and facilitates precise repositioning during deployment
- Physiological Valve Function: Avoids stenosis and maintains native flow dynamics
- Forward-Compatible Platform: Leaves room for future surgical or transcatheter mitral interventions
- Ease of Use: Designed for intuitive delivery and a short learning curve; early users note: “the catheters performed as expected… very intuitive”
Built on Rigorous Science
The CARLEN System development is supported by over 70 nonclinical studies, multiple bench validations, and now, First-in-Human success.
As Nyra progresses toward global expansion and a U.S. Early Feasibility Study, CARLEN is positioned to redefine what’s possible in transcatheter mitral repair — unlocking treatment for tens of thousands of patients currently left without options.
MRI Safety Information
The Cardiac Leaflet Enhancer (CARLEN) Implant is MR Conditional. A patient with the Cardiac Leaflet Enhancer (CARLEN) Implant may be safely scanned under the following conditions. Failure to follow those conditions may result in injury to the patient.
- Static magnetic field of 1.5 or 3 T, only
- Maximum spatial field gradient of 4,000-gauss/cm (40-T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg (Normal Operating Mode)
