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Atraverse Medical Secures FDA Approval for Left-Heart Access Device, Raises $12.5 Million

Atraverse Medical announced that its Hotwire radiofrequency guidewire left-heart access device has received clearance from the FDA.

This innovative device facilitates zero exchange left-heart access while serving as a guide for catheter-based therapy systems. Conceived by Steven Mickelsen, co-founder of Farapulse, and Eric Sauter, the Hotwire system marks another success for Mickelsen, following the recent treatment of the first patients by his company, Field Medical, in pulsed-field ablation.

Atraverse Medical’s device boasts universal sheath compatibility and optimized radiofrequency (RF) technology, with the aim of enhancing outcomes and streamlining procedural workflows.

“The FDA clearance of the Hotwire underscores our dedication to medical innovation and our commitment to improving the standard of care for procedures requiring transseptal access including endocardial ablation, left atrial appendage closure, and mitral valve repair,” Mickelsen said in a news release.

Dr. Devi Nair, director of cardiac electrophysiology and research at St. Bernard’s Medical Center, praised the system for its potential to revolutionize left-heart therapies, noting its ability to accommodate physicians’ preferred transseptal access workflows, which could lead to safer and more efficient procedures.

In addition to achieving regulatory approval, Atraverse has successfully closed an oversubscribed seed funding round, raising $12.5 million. Investors include physicians, venture capitalists, and leaders in the medical technology sector. The company intends to utilize these funds to accelerate research and development efforts and advance early commercialization initiatives.

“We are thrilled to have achieved FDA clearance in less than two years since founding the company, and the completion of our seed round positions Atraverse Medical for continued success in transforming the landscape of left-heart access,” said John Slump, co-founder, president and CEO.

© Atraverse Medical, Inc.

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