QUEBEC CITY, Oct. 26, 2022 /CNW Telbec/ - 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 the first cases in a clinical study, named SAFE-TAVI, studying SavvyWire™ left ventricular rapid pacing in transcatheter aortic valve replacement procedures, or TAVR, in Europe. Dr. Regueiro from Hospital Clnic de Barcelona, Spain, conducted the procedures as one of the primary investigators of the study. This study is part of the OpSens pre-CE mark clinical strategy that will lead to the commercialization of SavvyWire in Europe.
OpSens' SavvyWire has previously received Health Canada and U.S. FDA clearance. Using SavvyWire for left ventricular pacing can eliminate the need for venous access, reduce procedure time, and avoid potential complications associated with right ventricular pacing.
Dr. Josep Rods-Cabau, from the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Qubec or "IUCPQ"), is the global principal investigator of the SAFE-TAVI study that will enroll 120 patients with, among other conditions, severe aortic valve stenosis requiring a TAVR procedure in which left ventricular rapid pacing is considered necessary.
The SAFE-TAVI study is planned to be conducted at up to nine hospitals: in eight renowned centers across Spain and in Canada, at the IUCPQ. As the global principal investigator of the SAFE-TAVI study, Dr. Rods-Cabau will oversee and coordinate the principal investigators in their respective Spanish hospitals.
"I am extremely pleased with the performance of the SavvyWire," said Dr. Regueiro from Hospital Clnic de Barcelona. "We successfully used it on three cases today, implanting three different systems, including a NavitorTM TAVI System from Abbott, an Evolut system from Medtronic, and a SAPIEN 3 valve from Edwards Lifesciences. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while enhancing accuracy and patient safety."