inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for cardiac modeling.
France-based inHeart designed its inHeart Models software to enable the 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. FDA clearance allows for the expansion of the company’s commercial footprint in the U.S. to improve cardiac ablation procedures such as ventricular tachycardia (VT).
According to a news release, inHeart aims for its software to address the challenges of conventional VT ablation with its proprietary segmentation algorithm that analyzes preprocedural CT and or MR images to create highly detailed, interactive 3D models of the heart, giving physicians information that helps to optimize treatment strategies based on each patient’s unique cardiac anatomy.
The company said early clinical evaluations have shown the potential to reduce VT procedure times by 60% as compared to the conventional approach (reducing the time from five hours to less than two hours). Additionally, the evaluations have shown the potential for image-guided ablations to improve procedure success rates by 15%.
“This is an important commercial milestone for inHeart,” inHeart President and CEO Todor Jeliaskov said in the release. “With this clearance, we will grow inHeart’s presence in the U.S. as we work to improve patient care for long, complex cardiac arrythmias. Our goal is to make a VT ablation as straightforward as an atrial fibrillation (AF) ablation so that VT ablation is no longer limited to academic VT centers.”