FDA Clears Catheter with Integrated Intravascular Ultrasound Technology

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Provisio SLT IVUS System, which features a support crossing catheter that integrates intravascular ultrasound, enabling clinicians to assess blood vessel lumen and obtain vessel measurements at the same time through Sonic Lumen Tomography (SLT).

Provisio Medical , the manufacturer of the Proviso SLT IVUS System, said the Provisio SLT IVUS System’s inclusion of the SLT IVUS Support Crossing Catheter provides dual functionality in interventional procedures with an ultrasound transducer array at the distal end of the catheter.

Incorporating intravascular ultrasound capability into a front-line support crossing catheter may help simplify workflows, reduce iodinated contrast media (ICM) and reduce radiation exposure for patients being treated for peripheral vascular disease (PVD), according to Provisio Medical.

"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" noted S. Eric Ryan, M.D., the chief executive officer of Provisio Medical. "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."