Opsens has announced the successful treatment of 20 patients leading to the completion of the first in-man clinical study utilising the SavvyWire.
The wire was designed and developed to improve the intervention workflow for transcatheter aortic valve implantation (TAVI) and is the first guidewire able to both deliver a valvular prosthesis while allowing continuous haemodynamic pressure measurement during the procedure, Opsens said in a press release. The SavvyWire is not yet approved for commercialisation.
“We are extremely pleased to have completed this important safety and efficacy study with all patients successfully treated without any adverse effects related to the use of the SavvyWire,” said Louis Laflamme, president and chief executive officer of Opsens. “Structural heart procedures are rapidly growing worldwide, driven by the TAVI procedure and the expansion of its indications. As the TAVI procedure benefits a larger group of patients and with the minimalist approach growing in popularity within the medical community, the benefits of our product—the SavvyWire could be significant. The SavvyWire is an active guidewire that allows physicians to precisely deliver the valve and monitor deployment to ensure optimal implantation without guidewire exchanges. We believe the procedural benefits of our SavvyWire will improve the intervention and patient outcomes for TAVR procedures.”
The safety study was conducted with 20 patients in two world renowned structural heart institutions with Josep Rodés-Cabau (Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada) and Réda Ibrahim (Montreal Heart Institute, Montreal, Canada) as primary investigators.
Rodés-Cabau said: “This device has the potential to improve workflow and clinical outcomes in TAVI 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 optimising the intervention, in line with the evolution of TAVI through minimalist approach. We are proud to collaborate with Opsens to bring this leading-edge technology to market.”
Ibrahim added: “Pressure gradient is a hot topic in the TAVI landscape. Invasive pressure measurement has been critical for the adoption of TAVI, 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.”
Opsens is targeting the commercial launch of its SavvyWire in calendar year 2022.