OpSens SavvyWire Guidewire for TAVR Approved in Canada

April 26, 2022—OpSens Inc., a Québec City, Canada–based company focused on optical technology for cardiology device applications, announced that it has received Health Canada approval for the SavvyWire guidewire for transcatheter aortic valve replacement (TAVR).

According to the company, the SavvyWire is a third-generation, intelligent, preshaped, structural guidewire with integrated pressure monitoring that is designed to support the TAVR approach. The device is intended for improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. The device allows interventionalists to implant the percutaneous valve over the same device while obtaining continuous and accurate hemodynamic measurements to assist diagnosis.

In December 2021, the company announced it had filed for approval of the device with Health Canada and that it had also filed a 510(k) submission with the FDA for regulatory clearance of the SavvyWire TAVR guidewire in the United States.

Louis Laflamme, President and CEO of OpSens, commented in the company’s press release, “For OpSens, Health Canada’s approval is an important milestone on the path to the commercialization of the SavvyWire, which was specifically designed and developed to facilitate the procedure for TAVR. The introduction of a next-generation guidewire with the ability to deliver a prosthetic valve and designed for rapid pacing while allowing continuous measurement of hemodynamic pressure during the procedure is considered a significant benefit as the number of TAVR procedures is rapidly growing.”

Mr. Laflamme further advised, “We are prepared to initiate a phased commercialization in Canada over the coming months with a full launch expected toward the back half of 2022.”