OpSens has announced that it has received Health Canada approval to commence the first in-man study with its SavvyWire, transcatheter aortic implantation (TAVI) guidewire. The SavvyWire is the first guidewire intended to both deliver the aortic valve prosthesis while allowing continuous haemodynamic pressure measurement during the procedure.
“The SavvyWire has the potential to bring important innovation to physicians performing the TAVI procedure and could become a key advancement in performing the procedure. Studies continue to demonstrate the benefit of TAVI to a wide range of patients with severe aortic stenosis,” said Louis Laflamme, president and CEO of OpSens. “Health Canada’s approval of the first in-man study is an important milestone for the Company and an important step towards filing for 510k clearance with the US Food and Drug Administration (FDA). We remain on track to submit for regulatory approval in the USA in early 2022.”
Health Canada’s approval allows OpSens to commence the 20-patient study shortly at two structural cardiology institutions that contributed to the development of the device. Josep Rodés-Cabau at The Quebec Heart and Lung Institute Research Centre (IUCPQ, Université Laval, Quebec City, Canada) and Réda Ibrahim at The Montreal Heart Institute (MHI, Montreal, Canada) will be the primary investigators.