Opsens has filed a 510(k) submission with the US Food & Drug Administration (FDA) for regulatory clearance of its new guidewire, SavvyWire for transcatheter aortic valve implantation (TAVI). OpSens has also filed for approval with Health Canada.
“The FDA submission is a key milestone for OpSens, in introducing our innovative product to the cardiovascular market. The SavvyWire has been designed and developed to improve the workflow in transcatheter aortic valve replacement,“ commented Louis Laflamme, president and chief executive officer of Opsens. “The introduction of a novel and advanced guidewire that has the ability to both deliver a valvular prosthesis while allowing continuous haemodynamic pressure measurement during the procedure is considered to be a significant benefit to the medical community, especially given the rapid growth in TAVI procedures. We look forward to the agencies review of our application and will continue to prepare our organisation for an anticipated approval in late summer or fall of 2022.”
The SavvyWire, a pre-shaped, structural guidewire with integrated pressure monitoring, aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange, Opsens said in a press release. The device has been designed to support the minimalist TAVI approach which has been growing among structural heart physicians, the company adds.