Caranx Submits AI Software for Real-Time, Intra-Op TAVI Guidance to FDA

Caranx Medical announced U.S. Food and Drug Administration (FDA) submission of artificial intelligence (AI) software for real-time, intra-operative guidance of transcatheter heart valve implantation (TAVI).

According to the Caranx, this technology is a world first. The FDA submission is a milestone toward planned market introduction of its TAVIPILOT Soft by the end of 2025.

TAVIPILOT Soft tracks real-time anatomical and instrument landmarks, allowing precise and accurate heart valve positioning and delivery. The company expects it to be a revolution for transcatheter aortic valve replacement (TAVR) due to its being reserved for the most experienced cardiologists and centers.

It’s compatible with all cardiac imaging systems, Caranx said, and will be compatible with principal TAVI valves on the market.

“TAVIPILOT soft is a breakthrough for TAVI procedures, providing millimetric precision using augmented reality,” said Caranx co-founder and chief medical officer Eric Sejor. “Clinicians use precise preoperative images (CT-scan) for the planning of TAVI. However, during the procedure, they rely only on fluoroscopy, which shows the anatomy indirectly (requiring contrast injection) and transiently. Accurately positioning the valve requires long training and experience. Our TAVIPILOT Soft identifies key heart anatomical features for precise valve placement and is expected to transform TAVI procedures for patients and clinicians.”

“At Caranx Medical, our vision extends to developing our Artificial Intelligence Platform, currently containing more than 5000 annotated multimodality images of CT, Fluoroscopy, Echo, data, etc. used to feed our AI algorithms and to revolutionize other cardiovascular indications, such as mitral and tricuspid valve replacements, reshaping the landscape of interventional medicine,” added Caranx CEO Jorgen Hansen.