QUEBEC CITY, May 19, 2022 /CNW Telbec/ - OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary technology, today announced new data supporting the safety and efficacy of its SavvyWire recently approved by Health Canada for transcatheter aortic valve replacement (TAVR) procedures. The results of the 20 patient first-in-human clinical study of the SavvyWire were presented earlier today at the 2022 EuroPCR conference, and simultaneously published in the EuroIntervention journal.
The new clinical data presented by Dr. Josep Rodés-Cabau from the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec or "IUCPQ") support the safety and efficacy of the SavvyWire for TAVR procedures. A total of 12 patients received an Evolut PRO+ (Medtronic) valve and eight patients received a SAPIEN 3/ULTRA valve (Edwards Lifesciences). Patient enrollment was performed at IUCPQ by Dr. Rodés-Cabau and at the Montreal Heart Institute by Dr. Reda Ibrahim.
Appropriate left ventricular rapid pacing was achieved in all patients, resulting in an adequate reduction of aortic pressure. No procedural mortality, stroke, cardiac perforation, or guidewire malfunction were reported. Importantly, continuous, and accurate recording of pressure measurements during the TAVR procedures was achieved in all patients, with an excellent correlation between systolic and left ventricular end-diastolic pressure obtained using traditional pigtail catheters and the new SavvyWire.
"We are pleased by the new positive clinical data supporting our next-generation TAVR guidewire as we enter the commercialization phase of this innovative technology in Canada," commented Louis Laflamme, President and Chief Executive Officer of OpSens. "The SavvyWire is intended to simplify the TAVR intervention and facilitate the clinical decision-making process with the potential to transform the TAVR procedure."
The SavvyWire is a third-generation, intelligent and pre-shaped structural guidewire, with integrated pressure monitoring and the capacity to perform left ventricular pacing. This device aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange, in line with the minimalist approach.
TAVR Procedure Evolution
Aortic valve stenosis occurs when the heart's aortic valve narrows, which prevents the valve from opening fully, restricting blood flow from the heart into the main artery (aorta) and onward to the rest of the body.
Initially, the TAVR procedure was only indicated for inoperable patients and then for high-risk surgical patients. Clinical programs like ''PARTNER III'' and ''Evolut Low Risk'', have since shown better or equivalent clinical outcomes in intermediate and low-risk patients. The TAVR procedure is now evolving quickly with a minimalist approach that allows the procedure to be faster and the patients to be discharged earlier, sometimes on the same day.
The TAVR procedure is on the rise, driven by an aging of the population and recent studies that demonstrate its benefits to patients of all conditions.
OpSens focuses mainly 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 150,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.
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.
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SOURCE OpSens Inc.
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