Provisio Medical SLT IVUS System
Provisio Medical has announced that the Provisio SLT IVUS system has received FDA 510(k) clearance. The solution addresses previously unmet needs faced by vascular specialists and provides them with real-time, accurate, numeric measurements of the flow lumen of blood vessels, and limits image interpretation complexities.
According to the medical device specialist, its catheter is the first in the world to integrate intravascular imaging and support crossing catheter, while also enabling vessel lumen measurement and visualisation at the same time.
“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” said S. Eric Ryan, MD, Chief Executive Officer.
“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.”
Included within the Provisio SLT IVUS System are the SLT IVUS P1 system and the SLT IVUS Support Crossing Catheter. The latter is an over-the-wire ultrasound catheter with an ultrasound transducer array at the distal end. Data provided by the ultrasound signal can be used in a similar way to sonar technology to measure vessel dimensions in real time and also provide visualisation of the peripheral vessel’s flow lumen.