OpSens Inc. announced 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. 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.