Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

Shots:

• The US FDA has granted 510(k) clearance to TELLTALE for the prevention of coronary obstruction in pts undergoing Transcatheter Aortic Valve Replacement (TAVR) for both native aortic stenosis & bioprosthetic valve failure
• FDA cleared TELLTALE following a pivotal study demonstrating the device’s safety & effectiveness for leaflet modification in pts at risk of coronary obstruction
• TELLTALE, a Breakthrough-designated device, streamlines leaflet modification with precise, targeted radiofrequency laceration, offering predictable outcomes for patients previously deemed inoperable for whom mechanical options were limited

Ref: Businesswire | Image: Transmural Systems | Press Release

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