Opsens’ OptoWire III Fiber Optic Pressure Guidewire Receives CE Mark Approval

February 18, 2021—Opsens Inc. announced it has received European CE Mark approval for the OptoWire III, allowing the device to be marketed in the European Union, the Middle East, and Africa.

Based in Quebec City, Canada, Opsens is focused on coronary artery stenosis measurement in interventional cardiology procedures. Its flagship product, OptoWire, is a second-generation fiber optic pressure guidewire designed to diagnose and treat coronary disease by providing low drift and excellent lesion access. Opsens technology offers a choice between hyperemic indices, such as fractional flow reserve (FFR), and nonhyperemic indices, such as diastolic pressure ratio (dPR).

According to the company, the first interventional cardiologist to use the OptoWire III in Europe is Professor Pim Tonino, MD, who has extensive experience with all the pressure guidewires in the market and particularly with the OptoWire Deux. Prof. Tonino is with Catharina Hospital in Eindhoven, the Netherlands.

“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),” commented Prof. Tonino in Opsens’ press release.

He added, “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 nonhyperemic pressure ratios such as Opsens’ dPR.”

Also commenting in the company’s announcement, Zsolt Piroth, MD, with Goki Hospital in Budapest, Hungary, stated, “I am a firm believer in coronary physiology pre- and post-PCI. Usage of pressure guidewires has remained limited worldwide mostly due to device limitations. This wire is really unique and further supports what the clinical studies and medical societies recommend.”