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Quebec City, Canada, September 23, 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. Philippe Genereux, Director of the Structural Heart Program at Morristown Medical Center in New Jersey, and his team, performed the first use of SavvyWire in a transcatheter aortic valve replacement (TAVR) procedure in the United States.
"I am extremely pleased with the performance of the SavvyWire," said Dr. Genereux. "We successfully treated 10 consecutive patients with a variety of anatomies and levels of complexity including bicuspid valve, severe vessel tortuosity, horizontal aorta, failed prior surgical valve (valve-in-valve) using both balloon-expandable and self-expandable valves, and balloon valvuloplasty. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while enhancing accuracy and patient safety. I am excited to collaborate with OpSens to bring this disruptive technology to patients.”
"We are honored that Dr. Genereux, and the Morristown Medical Center team perform the first series of SavvyWire procedures in United States. Dr. Genereux’s prior work has been instrumental to the advancement and expansion of the TAVR field, and we are thrilled to be partnering with him and his team to streamline procedures and improve patient outcomes," said Louis Laflamme, President and CEO of OpSens.
"OpSens will conduct a controlled release to a limited number of hospitals in the U.S. through the end of 2022, then initiate full launch in early 2023."
SavvyWire is more than a wire, as the world’s first and only sensor-guided TAVR solution. It uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.
OpSens focuses mainly on 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 has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). This unique guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.
OpSens’ SavvyWire is on trend with a minimalist approach to TAVR and advances the procedure, allowing patients to leave the hospital earlier, sometimes the same day.
The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.
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.
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