Transmural Systems Receives FDA 510(k) Clearance for TELLTALE

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ANDOVER, Mass.--(BUSINESS WIRE)--Nov 21, 2025--

Transmural Systems, a leader in pioneering electrosurgical structural heart therapies, obtained 510(k) clearance from the United States Food and Drug Administration (FDA) for TELLTALE – the first and only cleared and dedicated electrosurgical guidewire system to prevent coronary obstruction in patients undergoing Transcatheter Aortic Valve Replacement (TAVR) for bothnative aortic stenosis andbioprosthetic valve failure.

FDA clearance for TELLTALE was granted after a comprehensive pivotal study highlighting the device’s safety and efficacy of leaflet modification in patients at risk for coronary obstruction. TELLTALE, which received Breakthrough Designation, streamlines leaflet modification providing precise, targeted laceration using radiofrequency energy, and delivers predictable outcomes for patients previously considered inoperable where mechanical solutions may fall short.

“At Transmural Systems, our mission has always been to simplify complex structural heart procedures through innovation,” says Kathleen Pizzuti, Chief Executive Officer of Transmural Systems. “The FDA’s clearance of TELLTALE reinforces our commitment to delivering a platform of intuitive, high-impact technologies that empower clinicians and improve patient outcomes.”

The National Institutes of Health (NIH) pioneered the BASILICA procedure to address the problem of coronary obstruction prior to TAVR. The TELLTALE system significantly simplifies BASILICA making it easier for physicians to adopt, ensuring broader accessibility. “We gratefully acknowledge Dr. Robert J. Lederman, Senior Investigator for Cardiovascular Intervention, and his research team at the National Institutes of Health (NIH) National Heart, Lung, & Blood Institute (NHLBI), and Toby Rogers, MD, of Medstar Washington Hospital Center, Jaffar Khan, MD, of St. Francis Hospital & Health Center, Vasilis Babaliaros, MD, of Emory University Hospital, and Adam Greenbaum, MD, of Emory University Hospital,” says Pizzuti. “Their contributions have been instrumental in advancing TELLTALE and achieving this significant milestone.”

ABOUT TRANSMURAL SYSTEMS: Transmural Systems aims to redefine care for structural heart failure by creating innovative solutions that make complex procedures safer and more reproducible. Founded in 2014, their technologies are designed to address high-risk cardiovascular interventions, particularly where conventional devices don’t meet the needs of patients.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251121990490/en/

CONTACT: Koosha Rafiee | V.P. Structural Heart Therapies

(832) 360-6070 |[email protected]

KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: FDA HEALTH CARDIOLOGY MEDICAL DEVICES

SOURCE: Transmural Systems

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PUB: 11/21/2025 08:43 PM/DISC: 11/21/2025 08:43 PM

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