Opsens, a company out of Québec, Canada, won FDA clearance for its OptoWire II optical guidewire that provides Fractional Flow Reserve (FFR) measurement, an indication of the extent of coronary stenosis. The nitinol-based device is an update on the previously available OptoWire I, but now features a new hydrophilic coating that makes delivery of the guidewire easier.
The company claims that its optical technology provides highly reliable readings not affected by the blood itself confusing the sensor.
“Very positive feedback on the performance of the OptoWire II, approval in the U.S. and the new production capability is galvanizing our plan, which is aimed at grabbing market share in the growing FFR market,” said Claude Belleville, Opsens’ Vice President, Medical Devices, in a statement. “We are committed to becoming the first choice of cardiologists, hence helping them to improve the clinical outcome of patients with coronary artery disease.”