­OpSens’ SavvyWire Included in Hemodynamics Substudy of COMPLETE TAVR

May 10, 2023—OpSens Inc., a Québec City, Canada–based company focused on optical technology with cardiology device applications, announced the inclusion of the company’s SavvyWire in the COMPLETE TAVR clinical study to investigate the impact of standardized invasive hemodynamics (SIH) during transcatheter aortic valve replacement (TAVR) procedures.

According to OpSens, the investigator-initiated COMPLETE TAVR study is sponsored by Edwards Lifesciences.

The COMPLETE TAVR study is a randomized, multicenter, open-label trial with blinded adjudication of outcomes. The study is planned to enroll 4,000 patients at up to 120 centers. It will determine whether a strategy of complete revascularization involving staged percutaneous coronary intervention 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.

OpSens stated that the SIH substudy using the SavvyWire will enroll up to 200 patients at up to 20 centers across the United States and Canada. The SIH substudy has started enrollment, and is anticipated to be completed later in 2023, with results anticipated early in 2024.

David Wood, MD, serves as global Principal Investigator of the COMPLETE TAVR study. Dr. Wood is with the University of British Columbia (UBC) in Vancouver, Canada, and is Director, UBC Center for Cardiovascular Innovation.

“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,” commented Dr. Wood in OpSens’ press release. Dr. Wood will provide updates on the progress of the study as more data become available.

OpSens’ SavvyWire is a sensor-guided TAVR solution that provides 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 has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for TAVR, advised the company.