OpSens has announced the commencement of the human clinical study utilising the SavvyWire, and successful treatment of the first patients. The SavvyWire, developed initially for transcatheter aortic valve implantation (TAVI), is intended to both deliver a valvular prosthesis while allowing continuous haemodynamic pressure measurement during the procedure.
“We are extremely pleased to have commenced this important safety study with the first two patients successfully treated with the SavvyWire. Structural heart procedures are a rapidly growing market, driven by the TAVI procedure and the expansion of its indications,” said Louis Laflamme, president and chief executive officer of OpSens. “As the TAVI procedure continues to benefit a wider range of patients and the minimalist approach grows in popularity, the benefit of a product like the SavvyWire could be significant. The SavvyWire is an active guidewire that allows physicians to deliver the valve, monitor deployment, and ensure optimal implantation without guidewire exchanges. We believe this could have procedural benefits and improve the security and efficiency of the procedure.”
The study will be conducted on 20 patients in two world renowned structural heart institutions with Josep Rodés-Cabau at the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada) and Réda Ibrahim at The Montreal Heart Institute in Montreal, Canada, as primary investigators.
Rodés-Cabau and Ibrahim commented: “Our two major cardiology centres in Quebec (IUCPQ and MHI), are proud to collaborate in the optimization of TAVI procedures by working with OpSens, an innovative Company on the cutting-edge of medical technology in the field of cardiology. 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.”
OpSens is targeting the commercial launch of its SavvyWire in calendar year 2022.