OpSens has announced that it has received Health Canada approval for the SavvyWire, its new guidewire for transcatheter aortic valve implantation (TAVI) procedures.
“For OpSens, Health Canada’s approval is an important milestone on the path to the commercialisation of the SavvyWire, which was specifically designed and developed to facilitate the procedure for transcatheter aortic valve replacement,” commented Louis Laflamme, president and CEO of OpSens.
“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 haemodynamic pressure during the procedure is considered a significant benefit as the number of TAVI procedures is rapidly growing. We are prepared to initiate a phased commercialisation in Canada over the coming months with a full launch expected toward the back half of 2022,” concluded Laflamme.
The SavvyWire, a third-generation, intelligent, pre-shaped, structural guidewire with integrated pressure monitoring, aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. This device is designed to support the growing minimalist TAVI approach. With the SavvyWire, physicians can expect to implant the percutaneous valve over the same device while obtaining continuous and accurate haemodynamic measurements to assist their diagnosis.