OpSens’ SAFE-TAVI Trial of SavvyWire Completes Enrollment in Europe

April 11, 2023—OpSens Inc. announced the completion of enrollment in the SAFE-TAVI clinical study, which is evaluating left ventricular rapid pacing using SavvyWire in transcatheter aortic valve implantation (TAVI) procedures in Europe. In the study, 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.

According to the company, the sensor-guided SavvyWire TAVI solution provides a three-in-one 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.

The SAFE-TAVI clinical study is being conducted as part of OpSens CE Mark clinical strategy for the commercialization of SavvyWire in Europe. In the United States, OpSens announced FDA clearance of SavvyWire in September 2022 and in April 2022, the company announced Health Canada approval for the SavvyWire guidewire.

The study, which commenced in October 2022, enrolled 120 patients with severe aortic valve stenosis and other conditions requiring a TAVI procedure in which left ventricular rapid pacing was considered necessary. SAFE-TAVI was conducted at eight centers in Spain and at the Quebec Heart and Lung Institute—Laval University (IUCPQ) in Quebec City, Canada.

Josep Rodés-Cabau from IUCPQ, who is the global Principal Investigator of the SAFE-TAVI study, oversaw and coordinated the principal investigators in their respective Spanish hospitals.

Dr. Rodés-Cabau commented in the OpSens press release, “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.”

He continued, “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 hemodynamic measurement during the TAVI procedure.”