Sam Brusco, Associate Editor05.24.22
inHEART, a company delivering a sophisticated “digital twin” of the heart, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its inHEART MODELS software suite for 3D anatomical structure visualization and analysis to use for pre-procedural planning and intra-procedurally.
The new software suite aims to improve efficiency and efficacy of cardiac ablation procedures like 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," Jeffrey Winterfield, MD, Chief of Arrhythmia Service and Hank and Laurel Greer Chair in Cardiac Electrophysiology at MUSC Health told the press. "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 tool addresses many conventional VT ablation challenges with a segmentation algorithm that analyzes pre-procedural CT and/or MR images to make detailed, interactive 3D heart models. The information gathered can help optimize treatment strategies based on unique cardiac anatomy, and supports integration into electroanatomic mapping systems.
Early clinical assessments showed the potential to lessen VT procedure times by 60% compared to the traditional approach—from five hours, to less than two. Image-guided ablations also demonstrated potential to grow rates of success by 15% compared to the conventional approach.
"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 ablation so that VT ablation is no longer limited to academic VT centers."
The new software suite aims to improve efficiency and efficacy of cardiac ablation procedures like 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," Jeffrey Winterfield, MD, Chief of Arrhythmia Service and Hank and Laurel Greer Chair in Cardiac Electrophysiology at MUSC Health told the press. "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 tool addresses many conventional VT ablation challenges with a segmentation algorithm that analyzes pre-procedural CT and/or MR images to make detailed, interactive 3D heart models. The information gathered can help optimize treatment strategies based on unique cardiac anatomy, and supports integration into electroanatomic mapping systems.
Early clinical assessments showed the potential to lessen VT procedure times by 60% compared to the traditional approach—from five hours, to less than two. Image-guided ablations also demonstrated potential to grow rates of success by 15% compared to the conventional approach.
"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 ablation so that VT ablation is no longer limited to academic VT centers."