OpSens Announces Completion of Enrollment in SAFE-TAVI Study With SavvyWire in Europe
OpSens Announces Completion of Enrollment in SAFE-TAVI Study With SavvyWire in Europe
Quebec City, Quebec, April 11, 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, today 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.
