Posted by Michael Wonder on 15 Sep 2022
Opsens announces FDA clearance for the SavvyWire for use in transcatheter aortic valve replacement procedures
15 September 2022 - OpSens today announced that it has received 510(k) regulatory clearance from the US FDA for the SavvyWire, its new guidewire for transcatheter aortic valve replacement procedures.
The SavvyWire is the first and only sensor guided transcatheter aortic valve replacement procedure solution, designed to support transcatheter aortic valve replacement procedural efficiency and lifetime patient management.
