Transmural Systems wins FDA Clearance for electrosurgical guidewire designed to prevent coronary obstruction during transcatheter aortic valve replacement

Transmural Systems has received 510(k) clearance from the U.S. Food and Drug Administration for TELLTALE, an electrosurgical guidewire system designed to prevent coronary obstruction in patients undergoing transcatheter aortic valve replacement.

The company said TELLTALE is the first and only cleared device of its kind for use in both native aortic stenosis and bioprosthetic valve failure, expanding options for patients who are at high risk of complications during TAVR.

FDA clearance followed a pivotal study demonstrating the device’s safety and efficacy in modifying valve leaflets using radiofrequency energy. The system offers a precise, targeted laceration technique intended to deliver more predictable results than mechanical solutions that can fall short in complex cases.

“At Transmural Systems, our mission has always been to simplify complex structural heart procedures through innovation,” CEO Kathleen Pizzuti said in the announcement. “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.”

TELLTALE also builds on the BASILICA procedure pioneered by the National Institutes of Health to prevent coronary obstruction during TAVR. The company said its system significantly streamlines that technique, supporting wider physician adoption.

Pizzuti credited several major contributors for advancing the device, including Robert J. Lederman of the NIH’s National Heart, Lung and Blood Institute; Toby Rogers, MD, of Medstar Washington Hospital Center; Jaffar Khan, MD, of St. Francis Hospital & Health Center; and Emory University Hospital physicians Vasilis Babaliaros, MD, and Adam Greenbaum, MD.

“Their contributions have been instrumental in advancing TELLTALE and achieving this significant milestone,” she said.

Recent advances in structural heart and electrosurgical therapies

The clearance of TELLTALE comes as structural heart care continues to shift toward less invasive, catheter-based techniques supported by increasingly sophisticated imaging, electrosurgical tools and procedural planning technologies. Over the past decade, TAVR in particular has expanded from a therapy used primarily in high-risk surgical patients to an option for many with severe aortic stenosis. This growth has spurred innovations designed to address the remaining challenges of valve replacement in complex anatomies.

One major focus has been reducing the risk of coronary obstruction, a rare but serious complication that can occur during TAVR. Techniques such as BASILICA, which uses electrosurgical energy to intentionally split a leaflet to maintain coronary flow, laid the groundwork for purpose-built devices like TELLTALE that aim to make the procedure more predictable and accessible. These approaches reflect a broader trend toward integrating electrosurgery into structural heart workflows to enhance precision and reduce reliance on mechanical tools.

Advances in imaging and procedural planning software are also driving progress. High-resolution CT analysis, AI-enabled modeling and improved intraprocedural guidance allow physicians to better identify patients at elevated risk for obstruction, valve malposition or other complications. This has helped clinicians tailor procedural strategies and, in some cases, avoid open-heart surgery for patients previously considered inoperable.

At the same time, catheter-based therapies continue to diversify. Newer-generation valves offer enhanced durability and retrievability, while complementary devices aim to address issues such as paravalvular leak or annular sizing. Electrosurgical tools are increasingly being used not only for leaflet modification but also for precision tissue reshaping in other structural heart procedures.

Together, these advances point to a future in which individualized treatment planning, specialized electrosurgical devices and refined catheter-based approaches work in concert to expand the safety and reach of structural heart interventions—opening the door for more patients to receive minimally invasive care.