Johnson & Johnson recently announced the completion of its acquisition of Atraverse Medical.(1)
The Atraverse HOTWIRE™ transseptal access system combines a sheath-agnostic RF guidewire, a purpose-built RF generator and an in-sterile-field activation handpiece. Physicians can use the sheaths they already trust, while the operator stays inside the sterile field throughout the procedural workflow. Each element successfully solves multiple unmet needs: precision crossing, energy control, sterile-field workflow, and use environment stability.
According to Dr. Devi Nair, Director of Cardiac Electrophysiology at St. Bernard's Heart and Vascular Center, "Gaining safe and precise access to the left atrium remains one of the most critical steps in both electrophysiology and structural heart interventions. In my clinical experience, the HOTWIRE™ system delivers a level of control, accuracy, and procedural ease that meaningfully elevates the transseptal workflow... I believe this technology represents a true advancement in transseptal access."(2)
Atraverse selected Veranex for design and development services across the program including:
Regulatory consulting for the HOTWIRE™ RF Guidewire confirming the 510(k) pathway and predicate selection.
The HOTWIRE™ RF Generator. Industrial design, design engineering, mechanical engineering, UX/UI for the clinician interface, and prototype builds.
The HOTWIRE™ assessory Handpiece. Services provided include industrial design, design engineering, mechanical engineering, design assurance, and commercial manufacturing.
Veranex collaborated on the design, developed and delivered the handpiece from concept through regulatory submission and commercial manufacturing in 17 months. It received FDA clearance as part of the guidewire’s serial accessory kit submission in August 2025.
"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,” said Atraverse Co-founder, Co-inventor and COO Eric Sauter.(2)
“Veranex was a force multiplier for our internal engineering team and enabled us to reach the market in a very capital efficient manner,” Sauter told us. “Veranex’ ability to spin up cross-functional resources helped accelerate execution and goal achievement in a remarkably compressed timeline.”
"Historically speaking, the challenges and risks associated with needle-based left-heart access have been a frustration," said Dr. Mark Metzl, Section Chief, Cardiac Electrophysiology at Endeavor Health. “The fully-integrated HOTWIRE™ system meets these issues head on and delivers control, visibility, and efficiency — simplifying the process and improving workflow in our centers."(2)
Congratulations to the Atraverse team! We are proud of your accomplishments and proud to have played a role in them.
Tom Lutzow is Veranex VP Research & Design
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More specifically about medical device design at Veranex: A device has to fit the workflow it enters, not just the specification it was built to. Human Centered Design embeds user research, industrial design, and UX/UI expertise into the earliest phases of development, ensuring your device solves real workflow problems before engineering investments harden the design setting the stage for manufacturing transfer. Our teams run concept vision sprints that turn technology ideas into defensible product visions in weeks, balancing user desirability, regulatory pathways, business viability, and technical feasibility. Validated user needs flow directly into Preclinical Services, Clinical Research, Regulatory Affairs, and Medical Writing, so regulators see a coherent intended-use story and clinicians encounter a device they can operate safely in pivotal studies.