FDA clears new left-heart access system from Atraverse Medical

Atraverse Medical, a San Diego-based medtech startup, has received U.S. Food and Drug Administration (FDA) clearance for its Hotwire Transseptal Access System.

The newly cleared system includes the Hotwire RF Generator and the Hotwire RF Guidewire, which has already been used in nearly 2,000 heart procedures. The Hotwire RF Generator is the first left-heart access system built with impedance-guided technology that helps minimize RF exposure in the left atrium. The Hotwire RF Guidewire, meanwhile, was designed to provide precise left-heart access to electrophysiologists while serving as a rail for catheter-based treatments. According to Atraverse, it offers “universal sheath compatibility,” allowing users to stick with the technology they prefer during RF procedures.

“Gaining safe and precise access to the left atrium remains one of the most critical steps in both electrophysiology and structural heart interventions,” Devi Nair, MD, director of cardiac electrophysiology at St. Bernard's Heart and Vascular Center and the cardiologist who performed the first clinical cases with the full Hotwire system, said in a statement. “In my clinical experience, the Hotwire system delivers a level of control, accuracy, and procedural ease that meaningfully elevates the transseptal workflow.”

“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,” added Eric Sauter, co-founder and chief operating officer of Atraverse Medical and co-inventor of these devices.