Atraverse Medical Announces FDA Clearance of HOTWIRE™ RF Guidewire for Zero-Exchange Left Heart Access

San Diego-based medical device company Atraverse Medical recently announced FDA approval for its HOTWIRE™ Radiofrequency (RF) Guidewire, a novel device enabling left-heart zero exchange while also serving as a guidewire for catheter-based treatment systems. This milestone achievement marks a significant step forward for the company in commercializing first-class left-heart access technology.

HOTWIRE System, Invented by Atraverse Co-Founders Dr. Steven Mickelsen and Dr. Eric Sauter, Introduces a Paradigm Shift in Left Heart Access. With universal sheath compatibility and optimized radiofrequency technology, HOTWIRE aims to improve patient outcomes and streamline procedural workflows. Dr. Mickelsen, also a cardiac electrophysiologist at Scripps Hospital in La Jolla, California, commented, "FDA approval of HOTWIRE underscores our dedication to medical innovation and our commitment to raising the standard of care for procedures requiring transseptal access, including endocardial ablation, left atrial appendage closure, and mitral valve repair."

On May 18, 2024, Dr. Devi Nair, Director of Cardiac Electrophysiology and Research at St. Bernard Medical Center, along with other KOLs, will present their initial experience using HOTWIRE at the Heart Rhythm Society (HRS) conference in Boston, Massachusetts. Dr. Nair said, "I am excited about HOTWIRE's potential to drive impactful change in the field of left-heart therapies, enabling physicians to use their preferred transseptal access workflow and potentially achieve safer and faster procedures." Following its recent FDA approval, Atraverse Medical will conduct demonstrations of HOTWIRE in the company’s technology suite at the HRS exhibition hall. Prior to joining the HRS, Dr. Mickelsen will introduce this new device at the prestigious Stanford Biodesign New Arrhythmia Technologies session.

Today, Atraverse Medical also announced the oversubscription of its seed round. The company has secured a total seed investment of $12.5 million, reflecting investors' strong belief in the need for continued innovation in the left-heart access field. This funding round, which includes investments from world-class physicians, prominent venture capitalists, and successful medtech entrepreneurs, will accelerate the company’s R&D efforts and early commercialization plans. "We are thrilled to have received FDA approval in less than two years since the company's inception," said John Slump, CEO/President and Co-founder of Atraverse Medical. "The completion of the seed round positions Atraverse Medical for continued success in transforming the landscape of left-heart access."

Atraverse Medical is a medical device company pioneering the next generation of left-heart access technology. The company’s proprietary HOTWIRE™ system features universal sheath compatibility and optimized radiofrequency technology, designed to enhance treatment outcomes and streamline workflows for physicians treating cardiovascular diseases in millions of patients worldwide. Headquartered in San Diego, California, Atraverse was founded in July 2022 by the same founding team behind FARAPULSE (acquired in June 2021).

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Editor-in-Chief: Chen Baolin

Author of this article: Yunye Pavilion

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