Subject: FDA
inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION
System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions
CAMBRIDGE, Mass. and BORDEAUX, France, May 24, 2022 /PRNewswire/ -- inHEART, a privately-held medical device company delivering the world's most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance for its inHEART MODELS software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. With this clearance, inHEART will expand its commercial footprint in the United States to help improve the efficiency and efficacy of cardiac ablation procedures such as ventricular tachycardia (VT).
"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, MD, Chief of Arrhythmia Service and Hank and Laurel Greer Chair in Cardiac Electrophysiology at MUSC Health in Charleston, SC. "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 analyzes preprocedural CT and/or MR images to create highly detailed, interactive 3D models of the heart. This information allows physicians to optimize 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 5 hours to less than 2 hours). Shorter procedures are typically associated with superior safety and patient experience. In addition, these evaluations have demonstrated the potential for image-guided ablations to improve procedure success rates by 15%, as compared to the conventional approach (from 60% to 75%).¹
"This is an important commercial milestone for inHEART," said Todor Jeliaskov, President and CEO of inHEART. "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."
About inHEART
inHEART is committed to delivering the world's most sophisticated, AI-enabled, digital twin of the heart to advance the care of patients living with cardiac disease. We believe all patients deserve access to world-class expertise that guides and optimizes treatment strategies to support improved clinical outcomes and return patients to full, healthy lives. For more information, visit inheartmedical.com
- Jais P, CT/MRI-guided ventricular tachycardia ablation, EHRA 2021
SOURCE inHEART
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