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Provisio Medical's Provisio SLT IVUS™ System Granted FDA Clearance

Friday, April 26, 2024

Provisio Medical has announced the FDA's clearance of its Provisio™ SLT IVUS™ System, a significant advancement in vascular imaging technology. This system, based on Sonic Lumen Tomography (SLT), addresses a crucial need for vascular specialists by offering automatic, real-time, and precise numeric measurements of blood vessel lumens, eliminating the need for complex image interpretation.

What sets the Provisio system apart is its integration of intravascular imaging and support crossing catheter functionalities, making it the world's first of its kind.

This catheter allows for simultaneous visualization and measurement of vessel lumens, while also providing support for guidewire insertion and delivery of contrast agents.
The case of the approximately 20 million people in the U.S. affected by peripheral vascular disease.

 Provisio's innovation streamlines the acquisition and presentation of vessel sizing data without disrupting the physician's workflow, potentially reducing procedure time, contrast media usage, and radiation exposure.

Eemphasizes the significance of this advancement, stating, "Accurate intravascular measurements significantly enhance clinical outcomes in peripheral vascular disease. Adoption has been hindered by the additional time and training required for image interpretation.

SLT IVUS, seamlessly integrated into the peripheral vascular workflow, we anticipate increased adoption and improved outcomes for many more patients suffering from this condition."

The Provisio SLT IVUS System includes the SLT IVUS™ P1 System and the SLT IVUS™ Support Crossing Catheter. The latter functions as both an ultrasound device and a support crossing catheter, equipped with an ultrasound transducer array at its distal end.

Real-time ultrasound signal analysis, similar to sonar technology, enables accurate measurement and visualization of peripheral vessel flow lumens.

 

Source: prnewswire.com

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