San Diego-based medical device company Atraverse Medical announced the FDA clearance of its HOTWIRE radiofrequency (RF) guidewire, a novel device that enables zero exchange left-heart access while also acting as a rail for catheter-based therapy systems. The company also announced the oversubscription of its seed round at $12.5 million.
These achievements mark a significant step towards commercializing the company’s best-in-class left-heart access technology.
The funding includes investment from world-class physicians, reputable venture investors, and successful medtech entrepreneurs and will accelerate the company’s research and development efforts and early commercialization initiatives.
The HOTWIRE system (invented by Atraverse Co-Founders Dr. Steven Mickelsen and Eric Sauter) highlights a paradigm shift in left-heart access. With universal sheath compatibility and optimized RF technology, the HOTWIRE aims to improve patient outcomes and streamline procedural workflows.
KEY QUOTES:
“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.”
– Dr. Mickelsen, also a cardiac electrophysiology physician at Scripps Hospital in La Jolla, CA
“I am excited about the HOTWIRE’s ability to drive impactful change in the field of left-heart therapies, allowing physicians to use their preferred transseptal access workflow with the potential for safer, faster procedures.“
– Dr. Devi Nair, Director of Cardiac Electrophysiology and Research at St. Bernard’s Medical Center
“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.”
– John Slump, CEO/President and Co-Founder of Atraverse Medical
