Dec. 3, 2025 — Atraverse Medical, a medical device company developing 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 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 has been used 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 left-heart access system with impedance-guided technology 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.
For more information, visit https://atraversemedical.com.
November 14, 2025 
