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OpSens Announces Completion of Enrollment in SAFE-TAVI Study with SavvyWire in Europe
QUEBEC CITY, April 11, 2023 - OpSens Inc. announced the successful completion of enrollment in the SAFE–TAVI clinical study, studying left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation procedures (TAVI or TAVR), in Europe. The study enrolled 120 patients with severe aortic valve stenosis and other conditions requiring a TAVI procedure in which left ventricular rapid pacing was considered necessary.
The SAFE-TAVI study was conducted in nine hospitals including eight renowned centers across Spain and one in Canada, at Quebec Heart and Lung Institute – Laval University (IUCPQ). As the global principal investigator of the SAFE-TAVI study, Dr. Josep Rodés-Cabau from IUCPQ oversaw and coordinated the principal investigators in their respective Spanish hospitals. OpSens' SavvyWire was used for left ventricular pacing to evaluate the potential benefits of eliminating the need for venous access, reducing procedure time, and avoiding potential complications associated with right ventricular pacing.
"We successfully used the SavvyWire in a large variety of anatomies, implanting valves from all major companies, including Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific," said Dr. Rodés-Cabau. "Left ventricular rapid pacing is necessary to restrict the range of motion of the heart muscle during TAVI for optimal valve placement. The rapid pacing feature is important in SavvyWire's performance in addition to providing real-time, accurate hemodynamic measurement during the TAVI procedure."
"We are honored to partner with Dr. Rodés-Cabau and all investigators on SAFE-TAVI," said Louis Laflamme, President and CEO of OpSens. "His clinical work has been instrumental in the progression of the TAVI procedure and the treatment of aortic stenosis and many advances in cardiology. We anticipate the clinical data from the SAFE-TAVI study will be published later this year."
OpSens' received Health Canada and U.S. FDA clearance for SavvyWire in 2022. The SAFE-TAVI clinical study is being conducted as part of OpSens CE Mark clinical strategy for the commercialization of SavvyWire in Europe.
SavvyWire is more than a wire. It is the world's first and only sensor-guided TAVR solution. SavvyWire 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.
Learn more about the SAFE-TAVI study here: https://clinicaltrials.gov/ct2/show/NCT05492383.
About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)
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 200,000 patients in more than 30 countries. It is approved for sale in the United States, the European Union, the United Kingdom, 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.
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