Provisio SLT IVUS System Cleared by FDA

April 25, 2024—Provisio Medical announced FDA 510(k) clearance of the Provisio sonic lumen tomography (SLT) intravascular ultrasound (IVUS) system, which is designed to enable vessel lumen measurement and visualization simultaneously with guidewire support and delivery of radiopaque contrast agents.

Provisio Medical stated that the device’s SLT technology provides automatic, real-time, accurate, numeric measurements of the flow lumen of blood vessels without the complexities of image interpretation.

According to the company, the Provisio SLT IVUS system is composed of the SLT IVUS P1 system and the SLT IVUS support crossing catheter.

The SLT IVUS support crossing catheter is an over-the-wire IVUS catheter with an ultrasound transducer array at the distal end that also functions as a support crossing catheter. Information from the ultrasound signal is used similarly to sonar technology to measure vessel dimensions in real time and visualize the peripheral vessel’s flow lumen.

By incorporating its technology into a frontline support crossing catheter, Provisio is intended to simplify the acquisition and presentation of vessel sizing data without changing the physician’s workflow, while potentially reducing time for data acquisition, use of contrast media, and exposure to radiation, stated the company.