Caranx Medical has submitted TAVIPILOT Soft, an AI-based guide software for use during Transcatheter Aortic Valve Implantation (TAVI) or replacement procedures (TAVR), for approval by the US Food and Drug Administration (FDA).
The French company claims TAVIPILOT Soft, which tracks real-time anatomical and instrument landmarks with the aim of achieving precise and accurate heart valve positioning and delivery during implantation of replacement, is the first solution of its kind.
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According to Caranx, TAVI/TAVR is currently a somewhat limited procedure that is the domain of experienced cardiologists and centres. With its AI software, the company hopes to enable greater democratisation of practitioner access in conducting TAVI/TAVR procedures.
Caranx co-founder and CTO Pierre Berthet-Rayne explained: “Our software is designed to be user-friendly, ensuring that cardiologists and surgeons can integrate it seamlessly into their usual practice. TAVIPILOT Soft allows clinicians to position a prosthetic valve easily and with high precision, ensuring that more patients could benefit from a high quality of care.
“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,” added Caranx co-founder and chief medical officer Eric Sejor.
“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.”
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By GlobalDataWhile Caranx’s software will be compatible with all cardiac imaging systems and principal TAVI heart valves on the market, it hopes to use the software with its own TAVI PILOT robotic surgery system. The company is set to conduct the first-in-human trials of the autonomously controlled system later this year.
According to GlobalData analysis, the TAVR market is growing at a compound annual growth rate (CAGR) of 8.6% and will reach a valuation of almost $15bn by 2033.
In other TAVI news, US device giant Edwards Lifesciences recently reported that patients were experiencing “outstanding one-year outcomes” and lower rates of mortality after treatment with its SAPIEN 3 RESILIA heart valve.
Abbott recently began conducting the first-in-human procedures for its TAVI system for symptomatic severe aortic stenosis at the Republican Centre of Emergency Medicine in Tashkent, Uzbekistan.
