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