OpSens Announces Global SavvyWire™ First Commercial Use
OpSens Announces Global SavvyWire™ First Commercial Use
Dr. Josep Rodés-Cabau at the Quebec Heart and Lung Institute – Laval University and
Dr. Réda Ibrahim at The Montreal Heart Institute performed the first utilization simultaneously in Quebec City and Montreal
Quebec City, Quebec, June 7, 2022 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that Dr. Josep Rodés-Cabau at the Quebec Heart and Lung Institute – Laval University, in Quebec City and Dr. Réda Ibrahim at The Montreal Heart Institute (“MHI”) in Montreal, performed the first commercial cases with OpSens’ new SavvyWireTM (“SavvyWire”) guidewire in transcatheter aortic valve replacements, or TAVR procedures.
Dr. Rodés-Cabau commented, “SavvyWire optimizes the intervention, in line with the evolution of TAVR via the minimalist approach. The SavvyWire has unique properties that open the door to effective pacing, without the need for adjunctive devices or venous access. I am proud to collaborate with OpSens to bring this leading-edge technology to market.”
Dr Ibrahim said, “The SavvyWire allows me to have an efficient workflow while providing continuous and accurate hemodynamic measurements in an integrated manner in our cath lab. OpSens’ product supports our return to the accuracy of invasive pressure measurement while making the procedure safer and more efficient.”
Louis Laflamme, President and CEO of OpSens, said, “We are honored to see Drs. Rodés-Cabau and Ibrahim successfully use the SavvyWire for TAVR procedures in Canada. Their clinical work played a significant role in helping to advance the applications and market for TAVR. Structural heart procedures are rapidly growing worldwide, driven by the aging population and recent studies that demonstrate its benefit for a broader array of patients. As the TAVR procedure benefits a larger group of patients and with the minimalist approach growing in popularity within the medical community, the benefits of the SavvyWire could be significant.”
Following the marketing approval received from Health Canada ahead of schedule in April 2022, OpSens has begun a controlled release to a limited number of hospitals in Canada. U.S. Food and Drug Administration clearance is expected this fall, with full commercial launch in early 2023.
The SavvyWire, a third-generation, intelligent, pre-shaped, structural guidewire with integrated pressure monitoring, aims to improve procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. This device is designed to support the growing minimalist TAVR approach. With the SavvyWire, physicians can expect to implant the percutaneous valve over the same device while obtaining continuous and accurate hemodynamic measurements to assist their diagnosis.
About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)
OpSens focuses mainly 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.
About the Quebec Heart and Lung Institute – Laval University – (www.IUCPQ.qc.ca)
Every year, 13,757 people are hospitalized and 115,654 visits were made on an outpatient basis for 41,670 users. The service area is more than two million people, which represents approximately 30% of Quebec’s population. Affiliated with the Laval University, the institution counts on the cooperation and the dedication of over 3,500 employees, physicians, professionals, researchers, managers as well as volunteers for providing quality care and services to both hospitalized and outpatient clienteles. In particular, the Institute offers programs of specialized and ultraspecialized care and services to treat cardiovascular and respiratory diseases as well as those related to obesity. The Institute’s physicians as well as health professionals have extensive expertise and contribute advancing the science of medicine. It also has as its mission to assess technologies and intervention methods in health. The Institute’s Research Centre is recognized internationally for the quality of its science.
About the Montreal Heart Institute (www.icm-mhi.org)
Founded in 1954, the Montreal Heart Institute constantly strives for the highest standards of excellence in the cardiovascular field through its leadership in clinical and fundamental research, ultra-specialized care, professional training, and prevention. It is home to Canada’s largest cardiology research centre, cardiovascular prevention centre, and cardiovascular genetics centre. The Institute is affiliated with the Université de Montréal and has more than 2,000 employees, including 245 physicians and more than 85 researchers.
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