Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device.
The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It’s the latest good news for a Mickelsen-backed company after his Field Medical pulsed-field ablation company treated its first patients last week.
Atraverse Medical’s device features universal sheath compatibility and optimized radiofrequency (RF) technology. The company aims for Hotwire to improve outcomes while 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, said the system could “drive impactful change in the field of left-heart therapies.” He added that it allows physicians to use their preferred transseptal access workflow, potentially meaning safer, faster procedures.
In addition to the regulatory milestone, Atraverse secured an oversubscribed seed funding round worth $12.5 million. Investors include physicians, venture investors and medtech entrepreneurs. The company plans to use the funds to accelerate R&D and 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.
