OpSens (TSX:OPS; OTCQX:OPSSF) completed enrollment in the SAFE–TAVI clinical study, which is studying left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation (TAVI or TAVR) procedures 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.
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,” Dr. Josep Rodés-Cabau, principal investigator, said in a statement.
OpSens anticipates clinical data from the SAFE-TAVI study will be published later this year.
OpSens’ received Health Canada and 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.
