Transmural’s Telltale Guidewire System Cleared for Leaflet Modification in TAVR

December 1, 2025—Transmural Systems announced FDA 510(k) clearance for the company’s Telltale electrosurgical guidewire system to prevent coronary obstruction in patients undergoing transcatheter aortic valve replacement for both native aortic stenosis and bioprosthetic valve failure. Telltale previously received Breakthrough Device designation from the FDA, advised the company.

According to Transmural Systems, the FDA clearance for Telltale was granted after a comprehensive pivotal study of the device’s safety and efficacy of leaflet modification in patients at risk for coronary obstruction.

Telltale is intended to streamline leaflet modification and provide precise, targeted laceration using radiofrequency energy. It delivers predictable outcomes for patients previously considered inoperable where mechanical solutions may fall short, stated Transmural Systems.

The company stated that the Telltale system is designed to simplify BASILICA—bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction—to make the procedure easier for physicians to adopt and facilitate broader accessibility. The National Institutes of Health pioneered the BASILICA procedure to address the problem of coronary obstruction before TAVR, noted the company.