DASI Simulation’s Precision TAVI earns FDA clearance

DASI Simulations announced today it has received FDA clearance for its first product - Precision TAVI. DASI aims to deliver advanced, artificial intelligence (AI)-driven individualized computer predictive modeling for improved patient outcomes, enhanced lifetime planning, and reduced costs associated with treating structural heart disease.

“DASI Simulations empowers every heart team with critical insights guaranteeing the identification of the best possible care for individual patients, customized to their unique circumstances and anatomy, said Lakshmi (Prasad) Dasi, PhD, FACC, FAIMBE, founder and chief technology officer. “One surgery at a time, our technology helps avoid complications, repeated interventions, helps lifelong planning for optimal structural heart care, and has the potential to save billions in unnecessary costs from preventable complications.”

The need for pre-procedure TAVR modeling

More than five million Americans are diagnosed with heart valve disease each year.[i] Eventually, many of those patients will undergo surgery to replace the damaged valve. In fact, multiple interventions may be required over a lifetime, so planning for this care is essential.

Transcatheter aortic valve replacement (TAVR), a minimally invasive procedure, is becoming the standard of care for replacing diseased aortic valves. In TAVR, the physician accesses the heart with a small incision in the leg or groin, then feeds the catheter through a blood vessel, using advanced imaging to place a new replacement valve in the heart. In 2021, there were more than 91,000 TAVR procedures.[ii] TAVR reduces the need for, and the risks of, open-heart surgery.

Revolutionizing structural heart care

“Our goal is to enter into the market and demonstrate our value to physicians, providers and TAVR centers,” said founder and CEO Teri Sirset. “Receiving FDA clearance is a testament to our unwavering commitment to revolutionize healthcare through AI technology and personalized computer simulations. Our game-changing approach has paved the way for the first approved personalized computer simulations in the heart valve space. While the journey to approval typically spans years, we shattered expectations by achieving this milestone in less than 14 months. As a company founded in December 2019, before the onset of the global pandemic, we navigated through unprecedented challenges and built a robust infrastructure during the tumultuous times of COVID-19. This achievement showcases our resilience and dedication to transforming patient care, one groundbreaking innovation at a time.” 

The foundational technology for Precision TAVI was initially licensed through The Ohio State University (OSU), and subsequently through an inter-institutional agreement between OSU, Georgia Institute of Technology, Emory University, and Piedmont Hospital Atlanta.

"Georgia Tech is proud to have played a role in creating advanced AI-based technology that can revolutionize the decision-making process for efficient and optimal treatment planning, thereby improving patient outcomes." said Georgia Tech Vice President of Commercialization Dr. Raghupathy Sivakumar.

[i] 18 Amazing Aortic Valve Replacement Statistics - HRF (healthresearchfunding.org)

[ii] https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/cardiac-surgeons-gaining-procedural-volume-despite