Opsens has received 510(k) clearance from the FDA for its OptoWire and OptoMonitor; its products that have been developed to measure fractional flow reserve (FFR). Claude Belleville, Opsens’ vice president medical devices, welcomed the approval and said that the company was “committed to becoming the first choice for cardiologists by delivering new, innovative guidewire technologies to measure FFR and improve the clinical outcome of patients with coronary artery disease.”
A press release reports that 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. It adds that the OptoWire is also designed to provide optimised performances to navigate coronary arteries and reach blockages with ease.
Louis Laflamme, Opsens’ president and chief executive officer, says: “Obtaining 510(k) clearance is a major regulatory achievement allowing Opsens to bring its products to the vital US market. The team members deserve the warmest congratulations for their successful execution of the rigorous provisions and directives. Their attention to details has enabled the rapid receipt of approvals in the US, in Japan and in Europe. We are proud of these milestones and committed to earning clinical and commercial success in all our markets.”