FDA clears updated FFR guidewire

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St. Jude Medical has received FDA clearance for multiple enhancements to its PressureWire fractional flow reserve (FFR) measurement guidewire.

FFR measurement identifies the severity of narrowings in the coronary arteries to allow for the assessment of coronary lesions for the treatment of coronary artery blockages, according to St. Jude, which is based in St. Paul, Minn.

The PressureWire with Agile Tip was designed to replicate the performance of standard PCI guidewires, the company said. The device is available in both of the company’s Aeris (wireless) and Certus PressureWire models. Another new feature in the next-generation PressureWire is a hydrophilic coating.