Atraverse Medical Gains FDA Breakthrough Clearance for HOTWIRE™ Transseptal Access System

Atraverse Medical has received FDA 510(k) clearance for its fully integrated HOTWIRE™ Transseptal Access System, which includes the HOTWIRE™ RF Generator and the HOTWIRE™ RF Guidewire. 

The system is designed to support safer and more controlled left-heart access by combining impedance-guided energy delivery with a zero-exchange guidewire compatible with all standard sheaths.

The HOTWIRE™ RF Generator, cleared in August 2025, features impedance-guided shutoff that stops energy once the transseptal crossing is completed, reducing the risk of unnecessary RF exposure in the left atrium. 

It also allows clinicians to activate energy within the sterile field for greater control. The HOTWIRE™ RF Guidewire, cleared in May 2024, has already been used in almost 2,000 clinical procedures. 

It supports zero-exchange left-heart access and offers enhanced echocardiographic visibility, increased rail stiffness and compatibility with all sheaths to improve workflow efficiency.

The full system provides an end-to-end, sheath-agnostic solution aimed at improving procedural control and consistency in electrophysiology and structural heart interventions. 

Early clinical use has shown improved control, visibility and overall workflow. Atraverse Medical views the clearance as a major milestone, reflecting years of focused development and creating new opportunities for broader clinical adoption and improved patient outcomes.