San Diego-based medical device company, Atraverse Medical, has announced the FDA clearance of its HOTWIRE™ radiofrequency (RF) guidewire. 

This device enables zero exchange left-heart access while also serving as a rail for catheter-based therapy systems, marking a significant milestone in the company's journey towards commercializing its leading left-heart access technology.

The HOTWIRE system, developed by Atraverse Co-Founders Dr. Steven Mickelsen and Eric Sauter, represents a paradigm shift in left-heart access. Designed with universal sheath compatibility and optimized RF technology, the HOTWIRE aims to enhance patient outcomes and streamline procedural workflows. 

Dr. Mickelsen, a cardiac electrophysiology physician at Scripps Hospital in La Jolla, CA, expressed his dedication to medical innovation and commitment to improving procedural standards, stating, "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."

During the upcoming Heart Rhythm Society (HRS) meeting in Boston, MA on May 18, 2024, Dr. Devi Nair, Director of Cardiac Electrophysiology and Research at St. Bernard's Medical Center, alongside other key opinion-leading physicians, will present their initial experiences with the HOTWIRE. Dr. Nair expressed enthusiasm for the device's potential to drive impactful change in left-heart therapies, facilitating safer and faster procedures.

Following the FDA clearance, Atraverse Medical plans to conduct demonstrations of the HOTWIRE at the company's tech suite in the HRS exhibit hall. Additionally, Dr. Mickelsen will introduce the device during the Stanford Biodesign New Arrhythmia Technologies Retreat.

In conjunction with the FDA clearance, Atraverse Medical announced the oversubscription of its seed round, securing USD 12.5 million in total seed investment. The financing, which includes investment from physicians, venture investors, and successful medtech entrepreneurs, will accelerate Atraverse Medical's research, development, and early commercialization efforts.

John Slump, CEO/President and Co-Founder of Atraverse Medical, expressed excitement for the company's achievements, stating, "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."