Atraverse Medical announced new clinical and preclinical data supporting its Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device. It enables zero-exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, a pioneer in the pulsed field ablation space, invented the Hotwire system with Atraverse co-founder Eric Sauter.
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The novel guidewire device initially received the FDA’s green light in May 2024. Another FDA clearance picked up in December 2025 included the system’s Hotwire RF (radiofrequency) generator, integrated with the guidewire. The generator mitigates the risk of uncontrolled energy delivery after accessing the left atrium. It can also activate energy within the sterile field to give clinicians more precise control.
The new data, shared at the AF Symposium in Boston, highlighted the safety, performance and workflow advantages of Hotwire.
Findings demonstrated reduced unintended tissue injury, low radiofrequency (RF) duration and consistent performance. Atraverse said the data reinforce the clinical value of Hotwire’s impedance-guided technology and zero-exchange approach to left-heart access.
Dr. Devi Nair presented the findings from approximately 500 patients with 100% procedure success. Nair reported zero adverse events as well.
“These data reinforce the clinical importance of controlled RF delivery and impedance-guided shutoff during transseptal access,” said Mickelsen, co-founder, co-inventor, and chief translational science officer of Atraverse Medical. “The consistency of results across preclinical and first-in-human studies highlights the strength of the Hotwire platform and its potential to set a new standard for left-heart access.”
