Transmural Systems Secures FDA 510(k) Clearance for TELLTALE, the First Dedicated Electrosurgical Guidewire System to Prevent Coronary Obstruction in TAVR
Transmural Systems, a medical technology innovator focused on advancing electrosurgical solutions for structural heart interventions, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking TELLTALE system. This landmark clearance makes TELLTALE the first and only dedicated electrosurgical guidewire system cleared in the United States specifically designed to prevent coronary obstruction during Transcatheter Aortic Valve Replacement (TAVR). The approval covers use in both native aortic stenosis and bioprosthetic valve failure, marking a significant step forward for patients at high risk of life-threatening complications during valve replacement.
The FDA’s decision follows an extensive and rigorous pivotal study demonstrating the safety, efficacy, and reliability of the TELLTALE system. This study highlighted the system’s unique capability to enable controlled and predictable leaflet modification—a technique essential for preventing coronary obstruction in high-risk patients. Because of its innovative approach and potential to address an unmet clinical need, TELLTALE previously received Breakthrough Device Designation, which facilitated increased collaboration with the FDA throughout the review process.
A Safer, More Predictable Approach to Leaflet Modification in TAVR
Coronary obstruction is one of the most feared complications of TAVR, particularly in patients with low coronary heights, narrow sinuses, or anatomical complexities common in both native and failed bioprosthetic valves. Traditional mechanical or catheter-based methods often fall short in the most complex anatomies, leaving select patients contraindicated for TAVR or at substantial procedural risk.
TELLTALE directly addresses these challenges by offering clinicians a dedicated electrosurgical solution engineered to deliver precise, targeted laceration of the aortic valve leaflet prior to TAVR deployment. Utilizing controlled radiofrequency (RF) energy, the system enables a clean, predictable split of the leaflet, allowing it to splay safely away from the coronary ostia when the new valve is implanted. This electrosurgical approach reduces technical variability and provides operators with a more standardized, intuitive toolset—whether performing leaflet modification in native valves or during valve-in-valve procedures for degenerated bioprosthetic valves.
The pivotal clinical study demonstrated that TELLTALE consistently delivered successful leaflet laceration with high procedural efficiency and a strong safety profile. Clinicians reported simplified workflow, improved visibility, and enhanced control compared to improvised or non-dedicated electrosurgical methods. These outcomes underscore TELLTALE’s potential to expand access to TAVR for thousands of patients who were previously considered unsuitable due to risk of coronary obstruction.
Executive Leadership Highlights Vision for Simplifying Structural Heart Care
Kathleen Pizzuti, Chief Executive Officer of Transmural Systems, emphasized that the FDA’s clearance is not only a technological milestone but also a testament to the company’s long-standing commitment to simplifying complex cardiac procedures.
“At Transmural Systems, our mission has always been to simplify complex structural heart procedures through innovation,” Pizzuti noted. “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.”
She added that TELLTALE reflects the company’s broader vision: to transform electrosurgical tools into mainstream, accessible, and highly effective solutions capable of reshaping how structural heart procedures are performed worldwide.
Building on the Legacy of the BASILICA Procedure
The TELLTALE system was inspired by—and designed to significantly simplify—the BASILICA procedure (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction), an electrosurgical technique pioneered by the National Institutes of Health (NIH). The BASILICA procedure has been instrumental in providing high-risk patients with an option for TAVR where mechanical solutions are inadequate; however, it is technically complex, resource-intensive, and requires advanced operator expertise.
In its original form, BASILICA involves modifying a standard guidewire and using external electrosurgical generators to create the leaflet laceration. This requires significant operator skill, specialized training, and precise coordination—factors that have limited widespread adoption despite the procedure’s proven effectiveness.
TELLTALE transforms this landscape by creating a fully integrated, purpose-built electrosurgical guidewire system. By streamlining workflow, eliminating improvisation, and standardizing both energy delivery and device handling, TELLTALE lowers the barrier to adoption for hospitals and clinicians while ensuring consistent and predictable procedural results. The system’s intuitive design supports faster setup, improved control, and greater reproducibility—addressing many of the practical challenges associated with BASILICA and making it accessible to a broader range of operators.
Recognition for Key Collaborators and Clinical Leaders
Transmural Systems credited a number of leading clinicians and researchers whose contributions were instrumental in the development, validation, and refinement of the TELLTALE system. Pizzuti expressed deep gratitude toward the key innovators behind the BASILICA technique and those who played central roles in TELLTALE’s clinical evaluation:
- Dr. Robert J. Lederman, Senior Investigator for Cardiovascular Intervention at the NIH’s National Heart, Lung, and Blood Institute (NHLBI), whose pioneering work laid the foundation for electrosurgical leaflet modification.
- Dr. Toby Rogers, MedStar Washington Hospital Center, known for his significant contributions to the clinical adoption and refinement of BASILICA.
- Dr. Jaffar Khan, St. Francis Hospital & Health Center.
- Dr. Vasilis Babaliaros, Emory University Hospital.
- Dr. Adam Greenbaum, Emory University Hospital.
These experts have collectively been on the forefront of advancing innovative structural heart techniques, and their dedication accelerated the path to FDA clearance.
“Their contributions have been instrumental in advancing TELLTALE and achieving this significant milestone,” Pizzuti stated.
A New Era for High-Risk TAVR Patients
The clearance of TELLTALE is expected to broaden the number of hospitals capable of performing leaflet modification and expand patient eligibility for TAVR—a treatment option increasingly favored for its minimally invasive nature and strong outcomes. With TELLTALE, physicians gain access to a tool that is more predictable, easier to use, and specifically engineered for preventing coronary obstruction, one of the most catastrophic complications associated with TAVR.
As TAVR continues to evolve and expand into younger, lower-risk, and more anatomically complex populations, technologies like TELLTALE will play a critical role in ensuring procedural safety and optimizing outcomes.
