Intellectual Property
Dr. Stuart Schecter, the founder of CardiaTouch, holds 25 U.S. patents, including coverage for the implementation of tactile and force feedback (haptic) technology for catheter-based cardiac procedures such as transseptal puncture, atrial fibrillation (AF) ablation, and mitral valve repair.
The Problem
Operators are unable to feel the cyclical effects of the heart’s motion or the affect of the patient’s breathing on the forces between inserted catheters and the heart’s tissues. This can lead to a host of complications including perforation of the heart and death. Recently published data speak to the fact that while the latest technologies (e.g., contact force displays for AF ablation) have provided us with tools and insights, these advances haven’t demonstrated improvements in outcome, do not prevent complications such as perforation of the heart, and exemplify the limitations of current invasive cardiovascular technologies. Procedural inefficacy and complications are primarily the result of inconsistent tissue contact and the application of excessive force, respectively.
CardiaTouch’s Solution
Central nervous system processing and motor reaction time to touch is faster than to visual stimuli. Haptic feedback improves attention, cognition, and performance (van Erp, 2007). The Multiple Resource Theory of attention explains that people have separate pools of attentional resources for the different sensory modalities. Haptic displays are particularly advantageous when auditory and visual channels are heavily loaded, providing faster reaction times than visual feedback alone, especially for alerting operators to unexpected high priority events (Calhoun et al., 2003).
CardiaTouch’s data has demonstrated that motor response time with the Haptic Handle is significantly shorter than to even constant visual feedback. Physicians can palpate blood flow, catheter contact force upon tissue, puncture of tissue planes, and beat to beat changes in blood pressure. This proof of concept data has been published and presented at international conferences. CardiaTouch has also completed and published animal studies demonstrating system operation during catheter-based delivery of radiofrequency ablation energy and capacity for seamless interface with commercially available contact force systems used to cure AF. United States Patents 7,963,925, 8,663,122, 8,942,828, 8,956,304, and 10,013,082 protect the commercialization of iterative technologies capable of recreating cardiac tissue motion, biophysical signals, and blood flow in a hand-held instrument as part of a catheter based system that will complement a number of cardiovascular procedures.
CardiaTouch initially aims to commercialize a Haptic Transseptal Puncture System. Complications from transseptal puncture, including perforation of the heart and death, occur in up to 3.6% of cases, as more inexperienced operators are now performing the procedure. The Haptic System is expected to dramatically reduce the learning curve, minimize risks from a necessary procedure for gaining access to the left side of the heart and outside epicardial surface, and save health care dollars. The market space covers multiple disease states including AF ablation and percutaneous mitral valve repair. Treatment of AF comprises over 400K hospital admissions/year and costs $26B in annual US expenditures. The population of patients with AF is expected to increase four-fold by 2050. Serious complications from AF ablation occur in up to 7.5%, with an astounding 1 in 238 patients dying as a result of the procedure when performed by inexperienced operators. Six million people in the US suffer from mitral disease, and Wall Street analysts consider this a multi-billion-dollar market with current sales of $250M worldwide, and projections for strong double-digit annual growth over the next several years. CardiaTouch has demonstrated that their Haptic System provides beat to beat palpation of catheter to tissue contact and anticipates major health care savings once their technology is used to cure the most common cardiovascular ailments.