Health Canada Approves Opsens's OptoWire and OptoMonitor FFR Devices

July 21, 2015—Opsens Inc. announced that it has received Health Canada's approval to commercialize the OptoWire and OptoMonitor, which are devices developed to measure fractional flow reserve (FFR).

The OptoWire is a nitinol-based optical guidewire for FFR that provides intracoronary blood pressure measurements using optical pressure guidewire technologies. It allows easy and reliable connectivity for reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to navigate coronary arteries and cross blockages with ease and safety.

In June, Opsens announced 510(k) clearance from the US Food and Drug Administration for the OptoWire and OptoMonitor, which have also earned regulatory approvals to commercialize in Japan and Europe.

In the company’s press release, Olivier F. Bertrand, MD, commented “With Opsens’ FFR products and their advanced fiber-optic technology, it will be easier and more reliable to assess coronary flow reserve and to decide whether patients require intervention or not. The interventional cardiology community has been eagerly waiting to have access to such improved technology. In today's world, this will help us provide optimized care.” Dr. Bertrand is a cardiologist at Quebec Heart-Lung Institute at Laval Hospital in Quebec City, Canada.