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Provisio Medical Announces FDA Clearance of the Provisio SLT IVUS™ System

Groundbreaking technology for the precise, automatic measurement of peripheral blood vessels to optimize treatment strategies

SAN DIEGO, April 25, 2024 /PRNewswire/ — Provisio Medical today announced FDA 510(k) clearance of the Provisio™ SLT IVUS™ System. Sonic Lumen Tomography (SLT) technology addresses a critical unmet need for vascular specialists by providing automatic, real-time, accurate, numeric measurements of the flow lumen of blood vessels without the complexities of image interpretation. Provisio Medical’s catheter is the world’s first integrated intravascular imaging and support crossing catheter and enables vessel lumen measurement and visualization simultaneously with guidewire support and delivery of radiopaque contrast agents. 

It has been demonstrated repeatedly that the current standard-of-care of using angiographic information by itself is insufficient to accurately assess vessel size1 in the approximately 20 million people in the U.S. with peripheral vascular disease2. The use of intravascular imaging has been shown to improve accuracy of vessel sizing and thereby improve clinical outcomes3. By incorporating its technology into a front-line support crossing catheter, Provisio simplifies the acquisition and presentation of vessel sizing data without changing the physician’s workflow, while potentially reducing the time for data acquisition, use of contrast media, and exposure to radiation.

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