Provisio SLT IVUS System Cleared by FDA

Provisio Medical has received U.S. Food and Drug Administration 510(k) clearance for the Provisio SLT IVUS System, a product that employs Sonic Lumen Tomography (SLT) technology to provide vascular specialists with automatic, real-time, accurate, numeric measurements of blood vessels’ flow lumen without the complexities of image interpretation.

Provisio Medical touts its catheter as the world’s first integrated intravascular imaging and support crossing catheter that enables vessel lumen measurement and visualization simultaneously with guidewire support and radiopaque contrast agent delivery.
 
It has been repeatedly shown the current standard-of-care of using angiographic information alone cannot accurately assess vessel size¹ in the approximately 20 million peripheral vascular disease patients in the United States.² Intravascular imaging can improve vessel sizing accuracy and thereby enhance clinical outcomes.³ 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, contrast media use, and radiation exposure.
 
“Clinical outcomes in peripheral vascular disease have consistently been shown to benefit from accurate intravascular measurements, yet adoption has been limited by the additional procedure time and training required to interpret images” Provisio Medical CEO S. Eric Ryan, M.D., said. “Thanks to the ease-of-use of SLT IVUS, which can be incorporated more efficiently in the peripheral vascular workflow, we believe there is the possibility of increased adoption and therefore improved outcomes for many more patients with potentially devastating peripheral vascular disease.”
 
The Provisio SLT IVUS System consists of the SLT IVUS P1 System and the SLT IVUS Support Crossing Catheter. The SLT IVUS Support Crossing Catheter is an over-the-wire intravascular ultrasound catheter with an ultrasound transducer array at the distal end that also functions as a support crossing catheter. The 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.
 
Provisio Medical is a medical device company based in San Diego, Calif., that aims to establish a new standard in vessel sizing, a critical step in millions of endovascular procedures performed annually. Provisio’s SLT IVUS technology, which is incorporated into catheters that physicians are already using, is designed to give clinicians the information they need, when needed, while enhancing procedural workflow.

References
¹ Pliagas G, Saab F, Stavroulakis K, Bisdas T, Finton S, Heaney C, McGoff T, Hardy K, Adams G, Mustapha JA. Intravascular Ultrasound Imaging Versus Digital Subtraction Angiography in Patients with Peripheral Vascular Disease. J Invasive Cardiol. 2020 Mar;32(3):99-103.
² Yost, Mary L., The True Prevalence of PAD and the Economics of Major Amputation, Endovascular Today, May 2021
³ Secemsky EA, Parikh SA, Kohi M, Lichtenberg M, Meissner M, Varcoe R, Holden A, Jaff M, Chalyan D, Clair D, Hawkins B, Rosenfield K. Intravascular ultrasound guidance for lower extremity arterial and venous interventions. EuroIntervention. 2022 Sep 20;18(7):598-608. doi: 10.4244/EIJ-D-21-00898. PMID: 35438078; PMCID: PMC10331977.