Caranx Medical Advances with FDA Submission of AI-driven TAVIPILOT

Caranx Medical Announces FDA Submission of TAVIPILOT Soft

Caranx Medical, a pioneering French medical device company, is taking a monumental step in the world of cardiology with the FDA submission of TAVIPILOT Soft. This is not just any product; it's the world's first AI software designed for real-time intra-operative guidance during transcatheter heart valve implantation procedures. The team at Caranx is dedicated to democratizing access to lifesaving Transcatheter Aortic Valve Implantation (TAVI), making this announcement a significant milestone in their ambitious journey.

A Major Milestone in Cardiovascular Innovation

The FDA submission represents a crucial point on Caranx's roadmap towards the planned launch of TAVIPILOT Soft by the end of 2025. Achieving this milestone has been a focus for Caranx, indicating their commitment to transforming the landscape of heart valve procedures through cutting-edge technology.

Jorgen Hansen, CEO of Caranx, expressed his enthusiasm: "The submission to the FDA is a significant step that offers a glimpse into the future of heart procedures. We believe that with real-time guidance provided by TAVIPILOT Soft, we can enhance the accuracy and precision of heart valve positioning, ultimately leading to better outcomes for patients. Our goal is not only to innovate but also to ensure that TAVI becomes more predictable and controlled."

Empowering Cardiologists and Expanding Access

One core aspect of Caranx’s mission is to broaden access to TAVI procedures. Philippe Pouletty, MD, a founder of Caranx and CEO of Truffle Capital, underscored this vision: “Our AI-driven software is key to enabling more cardiologists and surgical centers to provide complex TAVI procedures. At its heart, our initiative aims to save lives”.

The software is designed to integrate seamlessly into the current practices of cardiologists and surgeons. Pierre Berthet-Rayne, co-founder and CTO of Caranx, elaborated on this user-friendly approach, stating, “The TAVIPILOT Soft software ensures clinicians can position prosthetic valves with high precision, which will benefit a broader patient population.”

Transforming TAVI Procedures with Precision Technology

The intricacies of the TAVI procedure pose significant challenges. TAVI was introduced about 20 years ago; however, it remains a technique where precision is critical. Each year, around 300,000 TAVI procedures are performed in regions including the USA and EU, yet an estimated 1.7 million patients require this life-altering procedure. The projected growth of the TAVI market is notable, with current valuations around $8 billion and an annual growth rate in double digits. Caranx is poised to tap into this opportunity, potentially transforming the lives of countless patients unable to access effective treatments.

The TAVIPILOT Soft operates with advanced AI capabilities to track real-time anatomical features, vastly improving the precision of heart valve positioning and delivery. This innovation is set to expand the capabilities of what was once a procedure only trusted to veterans in the medical field.

A Vision for the Future of Interventional Medicine

At the forefront of Caranx’s mission is their expansive vision for the future of cardiovascular care. Jorgen Hansen remarked, “Our AI platform consists of an extensive database of over 5000 annotated multimodal images, vital for advancing our algorithms and contributing to innovations in other areas of interventional medicine, including mitral and tricuspid valve replacements.”

Caranx is not just looking to make waves with TAVIPILOT Soft but is dedicated to reshaping the entire landscape of cardiac procedures through AI advancements.

About Caranx Medical

Caranx Medical is backed by a team of distinguished experts in the field. Founded by Philippe Pouletty, MD, who also serves as CEO of Truffle Capital, along with co-founders CMO Eric Sejor, MD, and CTO Pierre Berthet-Rayne, the company aspires to establish itself as a global leader in the emerging field of AI-assisted transcatheter heart valve implantation.

With plans to introduce their autonomous robotic solution in human studies by 2025, Caranx medical is well-positioned for rapid growth and commercialization of their revolutionary products.

Frequently Asked Questions

What is TAVIPILOT Soft?

TAVIPILOT Soft is the world's first AI-driven software designed for real-time guidance during transcatheter heart valve implantation procedures.

What are the expected benefits of TAVIPILOT Soft?

This software aims to enhance precision and accuracy in valve positioning, facilitating a broader access to TAVI procedures for more patients.

When does Caranx Medical plan to launch TAVIPILOT Soft?

The planned market introduction of TAVIPILOT Soft is expected by the end of 2025.

How does TAVIPILOT Soft improve TAVI procedures?

It uses AI technology to identify key anatomical features, providing real-time guidance to clinicians during valve placement, improving overall outcomes.

Who are the founders of Caranx Medical?

Caranx Medical was founded by Philippe Pouletty, MD, Eric Sejor, MD, and Pierre Berthet-Rayne, each bringing extensive expertise in medicine and technology.

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