OpSens Obtains CE Marking for the OptoWire III
OpSens Obtains CE Marking for the OptoWire III
Quebec City, Quebec, February 18, 2021 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary disease, has announced it has received CE marking for the OptoWire III, the latest generation of its flagship product. CE Marking allows 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,” concluded Mr. Laflamme.
Prof. Pim Tonino, at Catharina Hospital in Eindhoven (the Netherlands), has extensive experience with all the pressure guidewires in the market and particularly with the OptoWire Deux. He is the first interventional cardiologist to use the OptoWire III in Europe. “I have been using the OptoWire for many years – said Dr Tonino – 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,” he added.
“I am a firm believer in coronary physiology pre- and post-PCI – commented Dr. Piroth from Goki Hospital in Budapest (Hungary) – 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,” concluded Dr Piroth.
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. Based on Fidela,™, OpSens’ second-generation fiber optic sensor, the Company has developed the OptoWire III, the most efficient pressure guidewire in the industry, a product that fulfills several unmet needs of cardiologists for their most complex cases and their demands for performance, accuracy, and reliability.
Since the launch of the first OptoWire version, OpSens has continued and will continue to invest in research to further develop its product and offer a choice between hyperemic indices, such as FFR, which is performed while the heart is stimulated by the injection of medication and non-hyperemic indices, such as dPR, a measurement performed without heart stimulation and where accuracy is of the utmost importance.
OpSens focuses primarily on coronary artery stenosis measurement in interventional cardiology. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 100,000 patients in more than 30 countries worldwide. It is approved for sale in the United States, Japan, Canada, Europe, Middle East, and Africa.
OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.
Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.
Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.
For further information, please contact:
Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333
Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333