OpSens Announces Inclusion of SavvyWire in COMPLETE TAVR Study
OPSENS ANNOUNCES INCLUSION OF SAVVYWIRE™ IN COMPLETE TAVR STUDY
Quebec City, Quebec, May 10, 2023 – 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, is pleased to announce SavvyWire inclusion in the COMPLETE TAVR clinical study to investigate the impact of standardized invasive hemodynamics (SIH) during transcatheter aortic valve replacement or TAVR procedures.
COMPLETE TAVR, an Investigator Initiated Study sponsored by Edwards Lifesciences, will determine whether a strategy of complete revascularization involving staged percutaneous coronary intervention (PCI) using drug eluting stents to treat all suitable coronary artery lesions after successful balloon expandable TAVR, is superior to a strategy of medical therapy alone in reducing the composite outcome of cardiovascular death, new myocardial infarction, ischemia-driven revascularization or hospitalization for unstable angina or heart failure.
The COMPLETE TAVR study is a randomized, multicenter, open-label trial with blinded adjudication of outcomes with planned enrollment of 4,000 patients at up to 120 centers. The SIH sub-study using the SavvyWire will enroll up to 200 patients at up to 20 centers across the United States and Canada.
“We look forward to the results of the COMPLETE TAVR standardized invasive hemodynamics study, where SavvyWire has the potential to simplify both the acute and long-term hemodynamic assessment of patients post-TAVR,” said Dr. David Wood, Director, UBC Centre for Cardiovascular Innovation and global principal investigator of the COMPLETE TAVR study.
The SIH sub-study using SavvyWire has already started enrollment, and is anticipated to be completed later in 2023, with results anticipated early in 2024. Dr. Wood will provide updates on the progress of the study as more data becomes available.
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.
About COMPLETE TAVR (https://www.clinicaltrials.gov/ct2/show/NCT04634240)
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 more than 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.
For further information, please contact:
Louis Laflamme, CPA, President and Chief Executive Officer, 418.781.0333
John Hannigan, FCA, Chief Financial Officer, 418.781.0333