OpSens has received CE mark approval for the OptoWire III, the latest generation of its flagship product. The development will allow the OptoWire III to be marketed in the European Union, the Middle East and Africa (EMEA).
“We are pleased to obtain CE mark approval for the OptoWire III in EMEA,” said Louis Laflamme, president and CEO of OpSens. “This is another milestone for the company. Thanks to the OptoWire’s new design, our guidewire is even more user-friendly and reliable, which may increase its adoption with EMEA physicians and expand the assessment of cardiovascular artery stenoses using indices like Fractional Flow Reserve (FFR) and diastolic Pressure Ratio (dPR). This could result in better diagnoses and treatment for more patients.”
Pim Tonino (Catharina Hospital, Eindhoven, The Netherlands) is the first interventional cardiologist to use the OptoWire III in Europe. He said: “I have been using the OptoWire for many years and I consider it an excellent pressure guidewire to access coronary lesions, measure their severity with great accuracy, treat them when indicated and confirm effectiveness of the percutaneous coronary interventions (PCI). The OptoWire III provides steerability comparable to workhorse guidewires while providing even more accurate, reliable, and repeatable measurements. I also appreciate the possibility it offers to measure a variety of indices from FFR to non-hyperemic pressure ratios such as Opsens’ dPR.”
Accurate assessment of the severity of coronary artery disease is essential, and pressure guidewires have been shown to improve clinical outcomes when used to diagnose coronary artery stenosis.