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Devices Interventional Cardiology

 News Release - February 23, 2023

Transmural Systems Electrosurgical Guidewire System (TELLTALE) Used in First Procedure in United States in IDE Pivotal Study

ANDOVER, Mass., Feb. 23, 2023 -- (Healthcare Sales & Marketing Network) -- Transmural Systems the leader in transcatheter electrosurgery for structural interventions announced today successful first-in-human procedure with its TELLTALE electrosurgical guidewire system. The TELLTALE Guidewire System is the first and only dedicated electrosurgical solution to simplify the BASILICA-TAVR procedure for transcatheter traversal and laceration of native and bioprosthetic tissue in patients at risk for coronary obstruction or compromised coronary access.

The TAVR market is expected to be $10 billion by 2028 with the expansion into low-risk younger patients. However, Transcatheter Aortic Valve Replacement (TAVR) may cause life threatening coronary artery obstruction, whether implanted for native aortic stenosis or bioprosthetic valve failure. Coronary obstruction during TAVR is associated with up to 50% mortality. The TELLTALE guidewire may be used to lacerate both native and bioprosthetic valve leaflets to enable safe implantation of the TAVR by preventing coronary obstruction.

The first TELLTALE procedure in the United States was performed at St. Francis Hospital & Heart Center, Roslyn NY, by Dr. Jaffar Khan and team. "TELLTALE is a beautifully elegant and intuitive device that allowed us to successfully treat this patient with severe native aortic stenosis who was at high risk of TAVR-induced coronary obstruction," commented Dr. Khan. "The targeted leaflet was effectively lacerated within just a few minutes, allowing for safe implantation of the TAVR valve."

"Doctors Babaliaros and Greenbaum, Co-directors of the Structural Heart and Valve Center at Emory University in Atlanta, GA, and pioneers in the field propose that "Transcatheter electrosurgery-assisted BASILICA is the only 'tried and true' method to guarantee laceration while minimizing unwanted tearing or embolization of often heavily calcified leaflets. The Transmural Systems dedicated TELLTALE guidewire system is the first to accomplish this and promises to be a huge advance for those in need of leaflet modification prior to TAVR."

"The TELLTALE system will offer a much-needed treatment option for patients with native valves or failing bioprosthetic valves requiring a TAVR," said Dr. Toby Rogers, interventional cardiologist, and scientific lead for the MedStar Heart & Vascular Institute Structural Heart Disease program.

"We are very pleased with the start of enrollment in the United States allowing us to move forward with our clinical plan said Transmural Systems CEO Nasser Rafiee. We believe TELLTALE will provide the simplicity and reliability physicians have been asking for during BASILICA procedures. We expect to be the first dedicated electrosurgical leaflet laceration device coming to market as early as 2024."

About Transmural Systems

Transmural Systems is a medical device company with a platform of innovative electrosurgical therapies and new treatment options for patients suffering from heart failure. Transmural Systems is a privately held company located in Andover, MA.

Source: Transmural Systems

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