OpSens Completes Enrollment in First-in-Human Study of SavvyWire for TAVR Procedures

November 23, 2021—OpSens Inc. announced the completion of enrollment in the company’s first-in-human clinical study utilizing the SavvyWire.

According to the company, the SavvyWire was designed and developed to improve the intervention workflow for transcatheter aortic valve replacement (TAVR) by delivering a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

The safety study enrolled 20 patients at two centers. The study was led by Primary Investigators Josep Rodés-Cabau, MD, at The Quebec Heart and Lung Institute Research Center in Quebec City, Canada, and Réda Ibrahim, MD, at The Montreal Heart Institute in Montréal, Canada.

In the OpSens press release, Dr. Rodés-Cabau commented, “This device has the potential to improve workflow and clinical outcomes in TAVR patients, especially in specific clinical indications where pressure measurement is of major importance such as valve-in-valve and patients with small aortic annulus. The SavvyWire is optimizing the intervention, in line with the evolution of TAVR through minimalist approach. We are proud to collaborate with OpSens to bring this leading-edge technology to market.”

Dr. Ibrahim added, “Pressure gradient is a hot topic in the TAVR landscape. Invasive pressure measurement has been critical for the adoption of TAVR, and we slowly moved away by using echography. The OpSens device allows us to come back to the precision of invasive pressure measurement while making the procedure safer and more efficient. I have been a fan of the idea from the start and it's a pleasure to now see this concept becoming a reality.”

The SavvyWire is not yet approved for commercialization. OpSens is targeting the commercial launch of the SavvyWire in the calendar year 2022.