OpSens SavvyWire’s FIH Study Commences in Canada

October 13, 2021—OpSens announced commencement of the first-in-human clinical study of its SavvyWire and the successful treatment of the first patients in the study. On September 20, the company announced Health Canada approval to commence the study.

The company stated that the SavvyWire, developed initially for transcatheter aortic valve replacement (TAVR), is a guidewire intended to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure. The device is an intelligent guidewire with integrated pressure monitoring.

The study will enroll 20 patients in two centers led by Primary Investigators Josep Rodés-Cabau, MD, at The Quebec Heart and Lung Institute Research Center (IUCPQ) in Quebec City, Canada, and Réda Ibrahim at The Montreal Heart Institute (MHI) in Montréal, Canada.

In the company’s press release, Drs. Rodés-Cabau and Ibrahim commented, “Our two major cardiology centers in Quebec (IUCPQ and MHI) are proud to collaborate in the optimization of TAVR procedures by working with OpSens, an innovative company on the cutting edge of medical technology in the field of cardiology.”

They continued, “In the first cases performed simultaneously in Quebec City and Montreal, we were able to successfully deploy the two dominant valves on the market, an Edwards Sapien 3 Ultra valve in one patient and a Medtronic CoreValve Evolut Pro Plus in the other. This demonstrated the initial versatility of the SavvyWire.”

According to the company, the device is intended to improve preshaped, structural procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. This device has been designed to support the minimalist TAVR approach so physicians can expect to diagnose and implant the percutaneous valve over the same device while getting continuous and accurate hemodynamic measurements.

The commercial launch of the SavvyWire is targeted for calendar year 2022, advised OpSens.