Atraverse Medical Secures FDA 510(k) Clearance for HOTWIRE™ RF Generator & Fully Integrated Transseptal Access System

Atraverse Medical also approaches first 2,000 successful clinical procedures using the company's innovative HOTWIRE™ radiofrequency (RF) guidewire.

SAN DIEGO, Dec. 4, 2025 /PRNewswire/ -- Atraverse Medical, a medical device company pioneering next-generation left-heart access technology, has received 510(k) clearance from the U.S. FDA for its fully integrated HOTWIRE™ Transseptal Access System.

The novel system includes the HOTWIRE™ RF Generator (August 2025) featuring impedance-guided shutoff after transseptal crossing — mitigating the risk of uncontrolled energy delivery after accessing the left atrium — along with an ability to activate energy within the sterile field, giving more precise control to clinicians. The FDA 510(k) cleared HOTWIRE™ RF Guidewire (May 2024) has been utilized successfully in nearly 2,000 clinical procedures to date, and these new features are designed to enhance procedural control and workflow efficiency with an end-to-end, zero-exchange, sheath-agnostic solution.

The fully integrated HOTWIRE™ Transseptal Access System includes:

• HOTWIRE™ RF Generator: 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, and enabling user-controlled energy activation in the sterile field.
  
  
• HOTWIRE™ RF Guidewire: A zero-exchange guidewire with universal sheath compatibility, with a proprietary tip architecture that enhances echocardiographic visualization by 25%, and a reinforced core wire and polymer jacket with twice the rail stiffness of leading competitors for controlled advancement of large bore sheaths

Dr. Devi Nair, Director of Cardiac Electrophysiology at St. Bernard's Heart and Vascular Center and world-renowned key-opinion leader, conducted the first clinical cases with the full HOTWIRE™ system and will be presenting data at the upcoming AF Symposium on her experience.

"Gaining safe and precise access to the left atrium remains one of the most critical steps in both electrophysiology and structural heart interventions," said Dr. Nair. "In my clinical experience, the HOTWIRE™ system delivers a level of control, accuracy, and procedural ease that meaningfully elevates the transseptal workflow. I look forward to sharing these results at the AF Symposium, for I believe this technology represents a true advancement in transseptal access."

"Historically speaking, the challenges and risks associated with needle-based left-heart access have been a frustration," commented Dr. Mark Metzl, Section Chief, Cardiac Electrophysiology at Endeavor Health. "The fully-integrated HOTWIRE™ system meets these issues head on and delivers control, visibility, and efficiency — simplifying the process and improving workflow in our centers."

"The FDA clearance of the HOTWIRE™ system is a significant milestone for Atraverse — one made possible by the unwavering dedication, ingenuity, and technical excellence of our development team," said Eric Sauter, Co-founder, Co-inventor and COO of Atraverse Medical. "After three years of focused innovation, our integrated end-to-end system and intentionally-engineered RF generator now provides a seamless solution to a long-standing clinical challenge — unlocking new opportunities for commercial success and meaningful impact for clinicians and patients."

Cleared by the FDA in May 2024, the HOTWIRE™ RF Guidewire has been used in nearly 2,000 successful clinical procedures across diverse physician workflows as part of a limited market release. The device enables zero-exchange left-heart access and serves as a rail for catheter-based therapies. With universal sheath compatibility, HOTWIRE™ is designed to optimize transseptal access, streamline procedural workflows, and improve patient outcomes with the best-in-class platform 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, featuring universal sheath compatibility, 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