FDA approval granted for inHEART 3D imaging analysis software

inHEART’s 3D cardiac modelling solution

inHEART has received US Food and Drug Administration (FDA) 510(k) clearance for its inHEART Models software suite that enables 3D visualisation and analysis of anatomical structures for pre-procedural planning and intraprocedural use.

With this clearance, inHEART will expand its commercial footprint in the USA to help improve the efficiency and efficacy of cardiac ablation procedures such as ventricular tachycardia (VT), the company said in a press release.

“We have been using the inHEART solution in clinical research for several years. Now with its commercial availability, inHEART will become part of our standard of care for planning and guiding therapeutic interventions,” stated Jeffrey Winterfield (MUSC Health, Charleston, USA). “The detailed substrate information in the 3D models allows us to pinpoint with accuracy and precision the arrhythmogenic areas in the scar tissue and target our ablation strategy accordingly. This information is invaluable for simplifying and enhancing our approach to VT ablation therapy.”

The inHEART solution aims to address many of the challenges of conventional VT ablation with its proprietary segmentation algorithm that analyses preprocedural CT and/or MR images to create highly detailed, interactive 3D models of the heart. This information allows physicians to optimise treatment strategies based on each patient’s unique cardiac anatomy and supports pre-procedural planning and seamless integration into all major electroanatomic mapping (EAM) systems.

Early clinical evaluations have shown a potential to reduce VT procedure times by 60% as compared to the conventional approach (from five hours to less than two hours). Shorter procedures are typically associated with superior safety and patient experience.


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