How Carvolix Is Democratizing TAVR and Stroke Care with AI Robotics

As structural heart and neurovascular interventions enter a new era of intelligent automation, few leaders are pushing the boundaries as decisively as Philippe Pouletty, founder of Carvolix. Formed through the merger of Affluent Medical, Caranx Medical, and Artedrone, Carvolix is building a vertically integrated MedTech platform that combines AI-driven software, autonomous mini-robotics, advanced imaging, and next-generation implant technologies.

At the heart of its innovation roadmap is TAVIPILOT, an FDA-cleared AI-powered navigation platform designed to enhance precision and safety in transcatheter aortic valve replacement (TAVR), with robotic and neurovascular applications in development. By reimagining the catheterisation laboratory as an “aircraft cockpit” where AI augments physician control with real-time anatomical tracking and autonomous navigation Carvolix aims to simplify some of the most complex cardiovascular and stroke interventions, making them safer, scalable, and more accessible worldwide.

In this exclusive conversation with MedTech Spectrum, Pouletty shares how artificial intelligence is redefining procedural precision, what realistic autonomy in the cath lab looks like over the next five years, the regulatory lessons from securing U.S. FDA clearance, and how AI-enabled robotics could democratise access to life-saving interventions far beyond major urban centres.

Carvolix combines AI-driven autonomous mini-robots, advanced imaging, and catheter-based technologies. How does artificial intelligence specifically enhance precision, safety, and scalability in cardiac valve replacement and stroke interventions?

Artificial intelligence enhances precision by tracking anatomical and instrument landmarks in real-time, allowing for millimetric accuracy during procedures. The goal is for improved safety and accuracy in valve placement through AI-driven navigation and software that provides a more stable and controlled approach than manual methods, significantly reducing human error in complex manoeuvres. This technology promotes scalability by lowering the steep training curves typically required for such procedures, enabling a broader range of interventional cardiologists to perform life-saving treatments safely without years of additional specialised training.

The vision to make the catheterization lab “as autonomous and efficient as an aircraft cockpit” is ambitious. What level of procedural autonomy are you realistically targeting in the next five years, and how will human oversight remain integrated into the system?

Carvolix is targeting a level of autonomy where the majority of the intervention, particularly navigating through the complex vascular anatomy of the brain and heart, is guided autonomously. This "cockpit" approach allows for highly efficient, automated navigation while keeping the interventional cardiologist firmly in command. Human oversight remains central as the physician still manoeuvres the catheter and makes final clinical decisions, but their capabilities are augmented by the AI image guidance and robot to navigate through procedural complexity.

With TAVIPILOT already cleared by the FDA, how does this regulatory milestone accelerate Carvolix’s broader AI-driven roadmap, and what lessons have you learned about gaining approval for autonomous or semi-autonomous medical technologies?

The FDA clearance of TAVIPILOT Soft serves as a critical commercial and technological foundation, enabling an immediate launch in the U.S. market during the first quarter of 2026. This milestone accelerates the roadmap by validating the core AI software, which paves the way for the clinical and regulatory progress of the more advanced TAVIPILOT Robot. A key lesson learned is that securing early regulatory approval for software-driven tools provides a strategic advantage and a proven pathway toward the goal of listing on the Nasdaq in 2027.

Only a small percentage of eligible patients currently receive TAVR or mechanical thrombectomy. How can AI-enabled robotics help democratize access to these complex procedures beyond major urban medical centres?

Currently, only a small fraction of eligible patients receive treatment, specifically 17 per cent for TAVR, 4% for mitral valve repair, and 5 per cent for ischemic stroke victims, due to the complexity of the procedures and a shortage of experts. AI-enabled robotics help democratize access by simplifying these interventions, allowing cardiologists in a wider range of medical centres to perform them safely without needing to be elite specialists. 

The merger of Affluent Medical, Caranx Medical, and Artedrone creates a vertically integrated MedTech platform. How will combining micro-robotics, AI software, and implant technologies shorten development cycles and reduce execution risk?

The merger creates a vertically integrated platform that combines breakthrough implants from Affluent Medical and AI software and robotic solutions from Caranx and Artedrone. This integration shortens development cycles by allowing for the simultaneous engineering of the hardware and software that must work in tandem. By consolidating these technologies under one leadership team, Carvolix reduces execution risk through shared expertise and a deliberate strategy to industrialize these innovations at scale.

Looking ahead, how do you see AI transforming interventional cardiology more broadly? Will the industry move toward fully autonomous procedures, AI-assisted decision-making, or hybrid human-machine collaboration models?

AI is set to transform interventional cardiology by evolving the cath lab into a high-tech environment where AI handles complex navigation and standardises outcomes. The industry is moving toward a hybrid human-machine collaboration model, where the "21st-century interventional cardiologist" uses AI and robotics to enhance their precision and reach. The ultimate objective is not to replace the physician but to empower them through AI-assisted decision-making and autonomous navigation to save more lives globally.