Sensor-guided TAVR guidewire gains FDA clearance
OpSens Inc. announced that it received 510(k) clearance from the FDA for its new guidewire for transcatheter aortic valve replacement procedures.
The product (SavvyWire) is the first sensor-guided TAVR guidewire, and it enables multiple steps over the same device without exchange, while delivering continuous hemodynamic measurements and display, according to a press release issued by the company.
“SavvyWire uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure and reliable left ventricular pacing without the need for adjunct devices or venous access,” Louis Laflamme, CPA, CA, president and CEO of OpSens, said in the release. “We look forward to ... initiating our limited market release of the product to a select number of physician thought leaders during the coming weeks.”