SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software

SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

The TAVIPILOT robotic platform, developed by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The TAVIPILOT robotic platform includes the TAVIPILOT Software, Robot (when controlled by the user) and Loop (when guided by the Software). The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT devices facilitate accurate valve alignment and deployment, reducing operator variability. The robot is compatible with commercially approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.

Inclusion Criteria:

1. Patients aged ≥65
2. Indicated for transfemoral TAVR for severe aortic stenosis