Transmural Systems has bagged US FDA clearance for first-of-its-kind electrosurgical guidewire to prevent coronary obstruction during Transcatheter Aortic Valve Replacement (TAVR), a complication that can be fatal.

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions — and could rapidly expand access to a lifesaving technique once limited to only the most specialized centers.

The agency’s clearance follows a pivotal study demonstrating the system’s safety and effectiveness in modifying valve leaflets in patients at high risk of obstruction. Backed by Breakthrough Device designation, TELLTALE uses radiofrequency energy to deliver precise, targeted leaflet laceration, offering a predictable solution for patients who were previously deemed inoperable or poorly served by mechanical tools.

"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 BASILICA procedure, developed by the National Institutes of Health (NIH), first established a way to prevent coronary obstruction before TAVR by intentionally splitting valve leaflets. TELLTALE aims to take that technique mainstream, dramatically simplifying the workflow and lowering the barrier to adoption for physicians.

“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.”