Transcatheter leaflet augmenting repair (TLAR) is a physiologically apt approach to repair mitral regurgitation, which overcomes the risks associated with transcatheter edge-to-edge repair (TEER) technologies. Thus, patients with a variety of anatomies and etiologies can be addressed.

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Simplified clinical workflow

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As a single leaflet attachment implant, CARLEN builds upon the current clinical workflow for transcatheter mitral valve repair, and simplifies it further. The procedure is driven by ultrasound imaging, with use of fluoroscopy limited to only catheter positioning.

Trans-septal entry into left atrium

One step steerability towards the mitral valve

Single leaflet capture

Single leaflet enhancement with CARLEN

Complete repair of FMR

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CARLEN enables complete repair of FMR, without the risk of mitral stenosis. With a single leaflet attachment mechanism, multiple adjacent implants can be deployed from one commissure of the valve to another, without the fear of inducing mitral stenosis - a significant challenge with existing TEER devices

Before repair

Post-CARLEN repair

Safety

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CARLEN  endothelializes and develops a thin layer of native tissue over it, within 30 days after implantation. This makes the device very hemocompatible and eliminates the need for blood thinners. ​The leaflet still remains very pliable and mobility of the implant is preserved.