US FDA grants 510(k) clearance for SavvyWire TAVI guidewire


OpSens has received 510(k) regulatory clearance from the US Food & Drug Administration (FDA) for the SavvyWire guidewire for transcatheter aortic valve implantation (TAVI) procedures.

“For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment. The SavvyWire has been designed to provide best in class valve delivery capability and improve workflow in the TAVR procedure,” commented Louis Laflamme, president and chief executive officer of OpSens.

“SavvyWire uniquely 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. We look forward to introducing physicians to the SavvyWire at the upcoming TCT meeting in Boston later this week and then initiating our limited market release of the product to a select number of physician thought-leaders during the coming weeks,” concluded Laflamme.

The SavvyWire is the first and only Sensor-Guided TAVI solution, designed to support TAVR efficiency and lifetime patient management, OpSens said in a press release.


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