Canadian Manufacturing

Health Canada approves OpSens TAVR guidewire

The SavvyWire is designed to help improve procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange.

April 26, 2022   by CM Staff

QUEBEC CITY — Medical cardiology device company OpSens Inc. announced that it has received approval from Health Canada for its new SavvyWire.

The company’s latest piece of technology is a guidewire designed for transcatheter aortic valve replacement procedures otherwise known as TAVR.

“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 transcatheter aortic valve replacement,” said Louis Laflamme, president and CEO of OpSens in a statement.

“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. 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.”

Advertisement

The SavvyWire is designed to help improve procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange.

OpSens says that with the SavvyWire, physicians can implant the percutaneous valve over the same device while obtaining continuous and accurate hemodynamic measurements to assist their diagnosis.