TAVIPILOT
Caranx MedicalTAVIPILOT is a software used during transcatheter aortic valve implantation procedures (TAVI/TAVR). It detects and marks important landmarks on live fluoroscopic X-ray images to guide clinicians for precise valve positioning, helping improve procedure accuracy and patient outcomes.
Intended Use
TAVIPILOT is an intra-operative software providing real-time fluoroscopy detection, tracking and marking of the Non-Coronary Cusp and the prosthetic valve to guide prosthetic valve positioning during TAVI/TAVR procedures, intended for adults.
Technology
The device uses a trained AI/ML model to detect, track, and mark relevant cardiac anatomical landmarks on real-time 2D fluoroscopic images without requiring pre-acquired CT data, running on a specified Windows-based computing platform connected to FDA-cleared C-arm X-ray systems.
Performance
TAVIPILOT was tested for compatibility with FDA-cleared C-arm X-ray devices from major manufacturers and validated in multiple centers for accurate detection, tracking, and marking of the non-coronary cusp and prosthetic valve. It showed high accuracy (detection within 1-2 mm) and equivalent or better performance compared to the predicate device, across a representative diverse patient population.
Predicate Devices
No predicate devices specified
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