SAN
DIEGO, May 15, 2024 /PRNewswire/ -- Atraverse
Medical, a San Diego-based medical
device company, today announces the FDA clearance of its HOTWIRE™
radiofrequency (RF) guidewire, a novel device that enables zero
exchange left-heart access while also acting as a rail for
catheter-based therapy systems. This milestone achievement marks a
significant step towards commercializing the company's
best-in-class left-heart access technology.
The HOTWIRE system, invented by Atraverse Co-Founders Dr.
Steven Mickelsen and Eric Sauter, introduces a paradigm shift in
left-heart access. Featuring universal sheath compatibility and
optimized RF technology, the HOTWIRE aims to improve patient
outcomes and streamline procedural workflows. Dr. Mickelsen, also a
cardiac electrophysiology physician at Scripps Hospital in
La Jolla, CA, commented,
"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."
Dr. Devi Nair, Director of
Cardiac Electrophysiology and Research at St. Bernard's Medical
Center, along with other key opinion-leading physicians will
present their initial experience using the HOTWIRE during the Heart
Rhythm Society (HRS) meeting in Boston,
MA on May 18, 2024. "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," stated Dr. Nair. Following the recent FDA
clearance, Atraverse will conduct demonstrations of the HOTWIRE at
the company's tech suite in the HRS exhibit hall. Prior to HRS, Dr.
Mickelsen will introduce the new device during the prestigious
Stanford Biodesign New Arrhythmia Technologies Retreat.
Today, Atraverse Medical also announces the oversubscription of
its seed round. The company has secured $12.5 million of total seed investment,
demonstrating a strong investor belief in the need for continued
innovation in the left-heart access arena. This financing includes
investment from world-class physicians, reputable venture
investors, and successful medtech entrepreneurs and will accelerate
the company's research and development efforts as well as early
commercialization initiatives. John Slump, CEO/President and
Co-Founder of Atraverse Medical, remarked, "We are thrilled to
have achieved FDA clearance in less than two years since founding
the company, and the completion of our seed round positions
Atraverse Medical for continued success in transforming the
landscape of left-heart access."
About Atraverse Medical
Atraverse Medical is a medical
device company pioneering next-generation left-heart access
technology. The company's proprietary HOTWIRE™ system, featuring
universal sheath compatibility and optimized RF technology, aims to
enhance outcomes and streamline workflows for physicians treating
cardiovascular disease in millions of patients worldwide. Based in
San Diego, CA, Atraverse was
founded in July 2022 by the same
founding team as FARAPULSE (acquired in June
2021). For more information,
visit www.atraversemedical.com.
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SOURCE Atraverse Medical