Globe & Mail 08:07 AM EST, 12/13/2021 (MT Newswires) -- OpSens Inc. (TSX: OPS), a medical device cardiology-focused company, on Monday said that it has filed a 510(k) submission with the U.S. Food & Drug Administration for regulatory clearance of its new guidewire (SavvyWire) for transcatheter aortic valve replacement, or TAVR procedures. OpSens has also filed for approval with Health Canada.
"The FDA submission is a key milestone for OpSens, in introducing our innovative product to the cardiovascular market. The SavvyWire has been designed and developed to improve the workflow in transcatheter aortic valve replacement," said Louis Laflamme, President and CEO. "The introduction of a novel and advanced guidewire that has the ability to both deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure is considered to be a significant benefit to the medical community, especially given the rapid growth in TAVR procedures."
OpSens is preparing for an anticipated approval in late summer or fall of next year.