OpSens has announced that Philippe Genereux (Morristown Medical Center, Morristown, USA) has performed the first use of SavvyWire in a transcatheter aortic valve implantation (TAVI) procedure in the USA, following its recent 510(k) approval by the US Food and Drug Administration.
“I am extremely pleased with the performance of the SavvyWire,” said Genereux. “We successfully treated 10 consecutive patients with a variety of anatomies and levels of complexity including bicuspid valve, severe vessel tortuosity, horizontal aorta, failed prior surgical valve (valve-in-valve) using both balloon-expandable and self-expandable valves, and balloon valvuloplasty. There is no doubt the SavvyWire allowed us to optimise our efficiency and workflow, while enhancing accuracy and patient safety. I am excited to collaborate with OpSens to bring this disruptive technology to patients.”
SavvyWire is a sensor-guided TAVI solution, which, according to OpSens provides a three-in-one solution for stable aortic valve delivery and positioning, continuous accurate haemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.
OpSens plans a controlled release to a limited number of hospitals in the USA through the end of 2022, and will then initiate full launch in early 2023.