New Data Presented at AF Symposium Show Atraverse Medical's HOTWIRE™ System Mitigates Unintended Left Atrial Injury With Reduced RF Delivery

SAN DIEGO, Feb. 9, 2026 /PRNewswire/ -- Atraverse Medical today announced the presentation of new clinical and preclinical data at AF Symposium 2026 in Boston, further validating the safety, performance, and workflow advantages of the company's HOTWIRE™ Transseptal Access System.

Findings from three presentations demonstrated reduced unintended tissue injury, low radiofrequency (RF) duration, and consistent performance across diverse procedural workflows, reinforcing the clinical value of HOTWIRE™'s impedance-guided technology and zero-exchange approach to left-heart access.

• Large-Electrode, Impedance-Sensing RF Transseptal System Reduces Unintended Left Atrial Injury in an Ex Vivo Porcine Model, presented by Jeremiah Wasserlauf, MD, showed that the HOTWIRE™'s large-electrode, combined with an impedance-guided RF generator, resulted in zero unintended left atrial injury events compared to >50% with a small-electrode RF guidewire system, while significantly reducing RF duration and total energy delivery in an ex vivo porcine model.
• Evaluation of a Novel Impedance-Sensing RF Transseptal Guidewire in a Multicenter, First-in-Human Observational Study, presented by Devi Nair, MD, demonstrated that the HOTWIRE™ system, which utilizes impedance-sensing technology to detect entry to the left atrium, provided safe and consistent performance across a variety of procedure types, with low RF duration and total energy delivery while enabling a simplified, zero-exchange workflow. The multicenter first-in-human observational study included approximately 500 patients with 100% procedure success.
• Multicenter First-In-Human Experience of a Novel RF Transseptal Guidewire, also presented by Devi Nair, MD, demonstrated that the HOTWIRE™ RF Guidewire provided safe and effective left-heart access across a broad range of procedure types, introducer sheaths, and operator workflows, achieving 100% procedural success in more than 1,000 transseptal procedures, with 29% performed using a zero-fluoroscopy approach. No adverse events were reported, while enabling efficient transseptal access and a simplified workflow.

"These data reinforce the clinical importance of controlled RF delivery and impedance-guided shutoff during transseptal access," said Dr. Steven Mickelsen, Co-Founder, Co-Inventor, and Chief Translational Science Officer of Atraverse Medical. "The consistency of results across preclinical and first-in-human studies highlights the strength of the HOTWIRE™ platform and its potential to set a new standard for left-heart access."

The HOTWIRE™ Transseptal Access System combines a novel RF guidewire with a next-generation RF generator designed to optimize transseptal access, streamline procedural workflows and improve patient outcomes with the best-in-class platform for left-heart access.

The zero-exchange HOTWIRE™ RF Guidewire features universal sheath compatibility, a proprietary tip architecture that enhances echocardiographic visualization, and a reinforced core wire and polymer jacket with twice the rail stiffness of leading competitors for controlled advancement of large-bore sheaths. The HOTWIRE™ RF Generator is the first and only left-heart access system with impedance-guided technology that halts energy delivery upon transseptal crossing, minimizing unnecessary RF exposure in the left atrium. The system enables user-controlled energy activation directly within the sterile field, delivering an end-to-end, sheath-agnostic solution for left-heart access.

ABOUT ATRAVERSE MEDICAL
Atraverse Medical is a medical device company pioneering next-generation left-heart access and optimized RF technology. The company's proprietary HOTWIRE™ system is designed to enhance outcomes and streamline workflows for physicians treating cardiovascular disease in millions of patients worldwide. Based in San Diego, CA, Atraverse was formed in July 2022 by Dr. Steven Mickelsen, John Slump, and Eric Sauter—the same founding team that created FARAPULSE (acquired in June 2021). For more information, visit www.atraversemedical.com.

SOURCE Atraverse Medical