FDA Clears Opsens' FFR Products for U.S. Market

July 10, 2015 - Opsens Inc. announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to measure fractional flow reserve (FFR). This measure is used to optimize the diagnostic and guide the treatment of patients with coronary heart disease.

The OptoWire is a nitinol-based optical guidewire for FFR that provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. Its immunity to the adverse effects related to blood contact allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of use. The OptoWire is also designed to provide optimized performances to navigate coronary arteries and reach blockages with ease.

For more information: www.opsensmedical.com