Atraverse Medical Gains FDA Clearance for HOTWIRE Transseptal Access System

San Diego-based Atraverse Medical has secured FDA 510(k) clearance for its fully integrated HOTWIRE transseptal access system, marking a significant step for the company’s left-heart access portfolio. The system brings together the HOTWIRE RF Generator, cleared earlier this year, and the HOTWIRE RF Guidewire, which has already been used in nearly 2,000 clinical procedures since its 2024 authorization.

The HOTWIRE RF Generator features impedance-guided shutoff that automatically stops energy delivery once the atrial septum is crossed, helping reduce unnecessary exposure in the left atrium. It also allows clinicians to activate energy directly within the sterile field, giving them more control during high-precision steps. The paired RF guidewire offers universal sheath compatibility and includes design elements intended to improve visualization and stiffness for advancing large-bore sheaths.

Early users of the system highlighted its impact on procedure workflow. Dr. Devi Nair, Director of Cardiac Electrophysiology at St. Bernard’s Heart and Vascular Center, led the first clinical cases and said the device provides “a level of control, accuracy, and procedural ease that meaningfully elevates the transseptal workflow.” She plans to present her initial results at the upcoming AF Symposium. Dr. Mark Metzl of Endeavor Health said the system addresses long-standing challenges with traditional needle-based access, noting that it “delivers control, visibility, and efficiency” across a range of cases.

Atraverse Medical sees the clearance as a major step forward. Eric Sauter, the company’s co-founder and COO, said the achievement reflects three years of focused development. “Our integrated end-to-end system and intentionally engineered RF generator now provides a seamless solution to a long-standing clinical challenge,” he said.

With the combined system now cleared, Atraverse plans to expand availability beyond its limited market release. The company expects the HOTWIRE platform to play a broader role in streamlining transseptal access and supporting catheter-based therapies that rely on safe, consistent entry into the left atrium.