OpSens’ SavvyWire Guidewire for TAVR Submitted for FDA Clearance and Health Canada Approval

December 13, 2021—OpSens Inc. announced that it has filed a 510(k) submission with the FDA for regulatory clearance of its new SavvyWire guidewire for transcatheter aortic valve replacement (TAVR) procedures. OpSens has also filed for approval of the device with Health Canada. The company is headquartered in Quebec City, Canada.

According to the company, the SavvyWire is an intelligent, preshaped, structural guidewire with integrated pressure monitoring during TAVR. It is designed to diagnose and implant the percutaneous valve over the same device while getting continuous and accurate hemodynamic measurements. The device aims to improve procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange.

In November 2021, the company announced the completion of enrollment in the company’s first-in-human clinical study utilizing the SavvyWire. In that announcement, OpSens advised it is targeting the commercial launch of the SavvyWire in the calendar year 2022.