Atraverse Medical Gets FDA Clearance for Radiofrequency Guidewire

It enables zero exchange left-heart access while also acting as a rail for catheter-based therapy systems.

Atraverse Website Illustrations Product Overview 3
Atraverse Medical

Atraverse Medical, a San Diego-based medical device company, announces 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 HOTWIRE system, invented by Atraverse Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access. Featuring universal sheath compatibility and optimized RF technology, the HOTWIRE aims to improve patient outcomes and streamline procedural workflows. Dr. Mickelsen, also a cardiac electrophysiology physician at Scripps Hospital in La Jolla, CA, commented, "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. Devi Nair, Director of Cardiac Electrophysiology and Research at St. Bernard's Medical Center, along with other key opinion-leading physicians will present their initial experience using the HOTWIRE during the Heart Rhythm Society (HRS) meeting in Boston, MA on May 18, 2024. "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," stated Dr. Nair. Following the recent FDA clearance, Atraverse will conduct demonstrations of the HOTWIRE at the company's tech suite in the HRS exhibit hall. Prior to HRS, Dr. Mickelsen will introduce the new device during the prestigious Stanford Biodesign New Arrhythmia Technologies Retreat.

Today, Atraverse Medical also announces the oversubscription of its seed round. The company has secured $12.5 million of total seed investment, demonstrating a strong investor belief in the need for continued innovation in the left-heart access arena. This financing includes investment from world-class physicians, reputable venture investors, and successful medtech entrepreneurs and will accelerate the company's research and development efforts as well as early commercialization initiatives. John Slump, CEO/President and Co-Founder of Atraverse Medical, remarked, "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."

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