Transmural Systems Receives FDA 510(k) Clearance for TELLTALE
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 both native aortic stenosis and bioprosthetic valve failure.
