Atraverse Medical Secures US FDA Approval For HOTWIRE System

Atraverse Medical, a medical device company spearheading cutting edge left-heart access innovation, has reported the US FDA approval of its HOTWIRE radiofrequency (RF) guidewire, a novel device that empowers zero trade left-heart access while likewise acting as a rail for catheter-based treatment frameworks. This achievement accomplishment denotes a critical stage towards commercializing the organization's top tier left-heart access innovation.

The HOTWIRE framework, created by Atraverse co-founders Dr. Steven Mickelsen and Eric Sauter, presents a change in perspective in left-heart access. Highlighting general sheath similarity and upgraded RF innovation, the HOTWIRE plans to enhance patient and smooth out procedural work processes. 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.