FDA Clears New Features for St. Jude's PressureWire FFR Measurement Device

April 3, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced that it has received US Food and Drug Administration (FDA) clearance for multiple enhancements to the company's PressureWire fractional flow reserve (FFR) measurement guidewire for determining the functional severity of narrowings in the coronary arteries.

According to St. Jude, the PressureWire with Agile Tip was designed to replicate the performance of standard percutaneous coronary intervention (PCI) guidewires, enable handling in challenging anatomies, and deliver interventional tools more easily for faster and more cost-effective PCI. This eighth-generation guidewire is available in both of the company's wireless Aeris and Certus PressureWire models.

Another new feature in the next-generation PressureWire is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons, stated the company.