OpSens has announced the successful completion of enrolment in the SAFE–TAVI clinical study, studying left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation procedures (TAVI), 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 centres 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, 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.
“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,” said Rodés-Cabau. “Left ventricular rapid pacing is necessary to restrict the range of motion of the heart muscle during TAVI for optimal valve placement. The rapid pacing feature is important in SavvyWire’s performance in addition to providing real-time, accurate haemodynamic measurement during the TAVI procedure.”
“We are honoured to partner with Dr Rodés-Cabau and all investigators on SAFE-TAVI,” said Louis Laflamme, president and CEO of OpSens. “His clinical work has been instrumental in the progression of the TAVI procedure and the treatment of aortic stenosis and many advances in cardiology. We anticipate the clinical data from the SAFE-TAVI study will be published later this year.”
OpSens received Health Canada and US Food and Drug Administration (FDA) clearance for SavvyWire in 2022. The SAFE-TAVI clinical study is being conducted as part of OpSens CE mark clinical strategy for the commercialisation of SavvyWire in Europe.
