Atraverse Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its fully integrated Hotwire transseptal access system.
The novel system includes the Hotwire radiofrequency (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.
The US FDA 510(k)-cleared Hotwire RF guidewire has been utilised successfully in nearly 2,000 clinical procedures to date, the company says in a press release, and new features are designed to enhance procedural control and workflow efficiency with an end-to-end, zero-exchange, sheath-agnostic solution.
“Gaining safe and precise access to the left atrium remains one of the most critical steps in both electrophysiology and structural heart interventions,” said Devi Nair (St Bernard’s Heart and Vascular Center, Jonesboro, USA). “In my clinical experience, the Hotwire system delivers a level of control, accuracy, and procedural ease that meaningfully elevates the transseptal workflow.”
“Historically speaking, the challenges and risks associated with needle-based left-heart access have been a frustration,” commented Mark Metzl (Endeavor Health, Bannockburn, USA). “The fully-integrated Hotwire system meets these issues head on and delivers control, visibility, and efficiency—simplifying the process and improving workflow in our centres.”
“The US 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 chief operating officer 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.”
