Transmural Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for TELLTALE a dedicated electrosurgical guidewire system to prevent coronary obstruction in patients undergoing transcatheter aortic valve implantation (TAVI) for both native aortic stenosis and bioprosthetic 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, Transmural Systems said in a press release.
“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 TAVI. The TELLTALE system 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 NIH National Heart, Lung, & Blood Institute (NHLBI), and Toby Rogers of Medstar Washington Hospital Center, Jaffar Khan of St Francis Hospital & Health Center, Vasilis Babaliaros of Emory University Hospital, and Adam Greenbaum of Emory University Hospital,” says Pizzuti. “Their contributions have been instrumental in advancing TELLTALE and achieving this significant milestone.”
