Provisio Medical has secured the US Food and Drug Administration’s (FDA) 510(k) clearance of the Provisio Sonic Lumen Tomography (SLT) IVUS System.
SLT technology is a new advancement that supports vascular specialists. It provides automatic, real-time, and accurate measurements of blood vessel flow lumen, without the complexities of image interpretation.
Provisio Medical has developed what is claimed to be the world's first integrated intravascular imaging and support crossing catheter.
The Provisio SLT IVUS System enables simultaneous vessel lumen measurement and visualisation, along with guidewire support and radiopaque contrast agent delivery.
The company highlighted the inadequacy of relying solely on angiographic information for the accurate assessment of vessel size in the approximately 20 million US individuals with peripheral vascular disease.
Intravascular imaging, as facilitated by the Provisio SLT IVUS System, can significantly improve the accuracy of vessel sizing, potentially leading to better clinical outcomes.
By integrating its technology into a front-line support crossing catheter, Provisio aims to streamline the acquisition and presentation of vessel sizing data.
This integration is designed to fit seamlessly into the physician's existing workflow while bringing down the time needed for data acquisition, use of contrast media, and radiation exposure.
The Provisio SLT IVUS System comprises the SLT IVUS P1 System and the SLT IVUS Support Crossing Catheter, an over-the-wire intravascular ultrasound catheter comprising an ultrasound transducer array at the distal end, which also works as a support crossing catheter.
The ultrasound signal is used to measure vessel dimensions in real-time and helps visualise the peripheral vessel's flow lumen, akin to sonar technology.
Provisio Medical CEO S Eric Ryan said: “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.
“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.”
