Atraverse Medical has received the US Food and Drug Administration (FDA) clearance for its HOTWIRE left-heart access device, which is intended to streamline workflows for physicians treating cardiovascular disease.
The approval marks a step ahead towards commercialising the company’s left-heart access technology.
Designed to facilitate zero-exchange left-heart access, the HOTWIRE radiofrequency (RF) guidewire system serves as a support for catheter-based therapy systems.
The system has been invented by Atraverse Medical co-founders Dr Steven Mickelsen and Eric Sauter, representing a new approach to left-heart access.
Mickelsen said: “The FDA clearance of the HOTWIRE underscores our dedication to medical innovation and our commitment to improving the standard of care for procedures requiring transseptal access including endocardial ablation, left atrial appendage closure, and mitral valve repair.”
It is compatible with universal sheaths and features advanced RF technology, which is expected to enhance patient outcomes and simplify procedural processes.
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St Bernard’s Medical Center Cardiac electrophysiology and research director Dr Devi Nair and other key opinion-leading physicians will present their initial experience with the HOTWIRE system at the Heart Rhythm Society (HRS) meeting in Boston, US, scheduled for 18 May 2024.
Nair said: “I am excited about the HOTWIRE’s ability to drive impactful change in the field of left-heart therapies, allowing physicians to use their preferred transseptal access workflow with the potential for safer, faster procedures.”
Furthermore, Atraverse has announced the oversubscription of its seed funding round, which drew contributions from a mix of physicians, venture capitalists, and medical technology entrepreneurs.
The company has raised $12.5m, surpassing its initial target.
The funds will be used to further research and development, as well as to support the early stages of commercialisation for the HOTWIRE system.
