Press Release

MUNICH, GERMANY, October 30, 2024 / LARALAB GmbH, a pioneer in AI-driven medical imaging for cardiology and heart surgery, announces the launch of its new Mitral Valve Module. This addition to LARALAB’s suite is CE marked and marks a significant advancement in screening and decision-making for transcatheter mitral valve repair and replacement (TMVR).

Clinical Validation Demonstrates High Accuracy
The Mitral Valve Module’s performance was validated in two studies recently published and presented at New York Valves and EACTS in Lisbon. A study at the University Hospital of Hamburg-Eppendorf (UKE) showed strong agreement in mean values with Intraclass Correlation Coefficients (ICCs) at 0.91 or higher for Mitral Annulus measurements. Another multi-center trial with 181 CT datasets from patients screened for TMVR confirmed these strong results with ICCs between 0.87 and 0.94 for mitral annulus d-shape measurements. Both studies included a significant number of patients with challenging mitral annular calcification (MAC). [1,2]

Dr. Martin Beyer from UKE Hamburg commented on the module’s effectiveness: “LARALAB’s AI demonstrated reliable anatomic measurements compared to our manual measurements. It was particularly impressive to see such strong agreement in our cohort with many MAC cases and present AV devices.”

Fully Automated NEO-LVOT Prediction for TMVR
The latest release of the cloud-based software includes a TMVR workflow with device integration and a fully automated 3-dimensional Neo-LVOT analysis capable of providing instant measurements of all CT phases.
 
Enhanced Screening with REC Rapid Eligibility Check
The accurate and fully automated analysis provided by LARALAB’s REC - Rapid Eligibility Check, enables clinicians to identify viable treatment pathways in seconds. This capability allows innovative TMVR device companies to screen faster and evaluate more patients to identify suitable candidates for their trials.
 
About LARALAB GmbH
Founded in 2018 and based in Munich, LARALAB GmbH is dedicated to advancing the field of interventional cardiology with its proprietary deep learning and cloud technology. The company is focused on delivering innovative AI-based solutions for transcatheter therapies such as Mitral, Tricuspid, and Aortic Valve procedures. For more information about LARALAB and its new Mitral Valve Module, please visit www.laralab.com or contact office@laralab.de.
 
Disclaimer: The REC and the device-specific 3-dimensional Neo-LVOT module are currently limited to research use only.