OpSens SavvyWire Receives Approval to Commence First-In-Human Study

September 20, 2021—OpSens Inc. announced that it has received Health Canada approval to commence the first-in-human (FIH) study with its SavvyWire, which is a guidewire developed specifically for transcatheter aortic valve replacement (TAVR). The SavvyWire is intended to deliver the aortic valve prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

According to the company, Health Canada’s approval allows OpSens to commence the 20-patient FIH study at two world-renowned structural cardiology institutions that contributed to the development of the SavvyWire. The primary investigators will be Josep Rodés-Cabau, MD, at The Quebec Heart and Lung Institute Research Center in Quebec City, Canada, and Réda Ibrahim at The Montreal Heart Institute in Montréal, Canada.

“The SavvyWire has the potential to bring important innovation to physicians performing the TAVR procedure and could become a key advancement in performing the procedure,” commented Louis Laflamme, President and Cheif Executive Officer of OpSens, in the company’s press release. “Studies continue to demonstrate the benefit of TAVR to a wide range of patients with severe aortic stenosis.”

Mr. Laflamme further noted, “Health Canada’s approval of the [FIH] study is an important milestone for the Company and an important step towards filing for 510(k) clearance with the FDA. We remain on track to submit for regulatory approval in the United States in early 2022.”

OpSens, which focuses mainly on coronary artery stenosis measurement in interventional cardiology, currently offers an optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. The company’s OptoWire is a second-generation fiber optic pressure guidewire designed to provide low drift and excellent lesion access. It is approved for sale in the United States, European Union, Japan, and Canada.