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November 15, 2024
Press Release
LARALAB Releases CE Marked Aortic Valve Module: Advancing TAVR with Large-Scale AI-Driven Analysis
MUNICH, GERMANY, November 15th, 2024/ LARALAB GmbH, a leader in AI-powered medical imaging for interventional cardiology, announces the launch of its CE marked Aortic Valve Module. This module offers automated, high-precision segmentations and measurements, crucial for advancing Transcatheter Aortic Valve Replacement (TAVR) in patients with Aortic Stenosis (AS) or Regurgitation (AR).
Introducing New Capabilities to Advance TAVR
The release of the Aortic Valve Module aligns with the expansion of TAVR indications and the increasing demand for precise imaging analysis in decision-making. This module sets a new clinical practice benchmark, designed to provide an advanced, complementary tool that offers substantial value in the evolving TAVR landscape. LARALAB’s Aortic Valve Module is the only fully automated CE marked pipeline for TAVR, ensuring precise and large-scale CT analysis on the LARALAB Cloud Platform.
Significance of Automated Precision for TAVR
Recent results from the EARLY TAVR trial suggest that guidelines for treating severe AS may evolve to include earlier intervention, even for asymptomatic patients. Results from the Partner 3 and Evolut Low Risk trials have already demonstrated TAVR as a potentially viable option for patients at low surgical risk. In these trials, the role of anatomical factors was critical in determining patient eligibility. As the field advances, objective anatomical criteria are essential in clinical practice. LARALAB's new Aortic Valve Module, specifically designed for efficient processing of large volumes of CT data, enables trial coordinators to identify advanced anatomical criteria with precision. By integrating these insights into clinical workflows, patients who would benefit from TAVR can be quickly and accurately identified.
The Only Fully Automated CT Module for TAVR with Regulatory Approval
Due to LARALAB's validated, best-in-class AI, it is currently the only fully automated CT module for TAVR that has received regulatory approval (CE marked). Unlike other approved modules on the market, which require user input during workflow or in-house analysis, LARALAB's module is completely AI-based, enabling a seamless 'data in, results out' workflow. It has been trained with over 1.4 million annotated images, ensuring the highest precision and reliability.
Clinically Validated Accuracy
Dr. Mani Arsalan recently presented initial results at the DGK and ESC Congresses from a study involving a 100-patient dataset, which demonstrated strong agreement in mean values and ICCs between 0.96 and 0.98 for Aortic Annulus measurements [1][2]. Conducted at the University Hospital of Frankfurt and Gießen, this study underscores the module’s high precision and reliability. Further publications from multi-center trials, which include a total of 250 patients investigating the impact of AI-based measurements on valve selection are currently under review and are expected to be published in the spring of 2025.
About LARALAB GmbH
Founded in 2018 and based in Munich, LARALAB GmbH is dedicated to advancing the field of interventional cardiology through its proprietary deep learning and cloud technology. The company is providing innovative AI-based solutions for transcatheter therapies such as Mitral, Tricuspid, and Aortic Valve procedures. For more information about LARALAB and the new Aortic Valve Module, please visit www.laralab.com or contact office@laralab.de.
[1] Arsalan, Mani et al. "Fully automated CT analysis with a deep-learning based algorithm for pre-procedural planning in transcatheter aortic valve implantation". ESC Congress London (2024). Access here
[2] Arsalan, Mani et al. Vollautomatische CT-Analyse zur präinterventionellen Planung vor TAVI mittels deep learning Algorithmus: Vergleich zum Goldstandard. Clinical Research in Cardiology 113. (2024) Feb 26. doi: 10.1007/s00392-024-02406-5| Access here
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