FDA OKs Enhancements to St. Jude’s PressureWire System

St. Jude Medical Inc., has received U.S. Food and Drug Administration (FDA) clearance for enhancements to its PressureWire fractional flow reserve (FFR) measurement guidewire. The FFR is an index determining the functional severity of narrowings in coronary arteries.

Specifically, FFR identifies which narrowed arteries are responsible for significantly obstructing the flow of blood to a patients’ heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes. St. Jude’s PressureWire Aeris (wireless) or PressureWire Certus are used to measure FFR.

According to the St. Paul, Minn.-based company, the design of the PressureWire with Agile Tip replicates and improves the performance of standard percutaneous coronary intervention (PCI) guidewires. The new version of the PressureWire, available for both Aeris and Certus, is intended to improve the delivery of interventional tools for faster and more efficient PCI. This eighth generation guidewire also will feature a proprietary hydrophilic coating designed to reduce friction within guide catheters and stent delivery catheters, which should facilitate the deployment of stents and coronary balloons.

The FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study of January 2009, conducted by St. Jude Medical, showed that integrating FFR into routine lab procedures reduces the risk of death or heart attack by 34 percent.

St. Jude acquired the PressureWire system following its 2008 purchase of Sweden-based Radi Medical Systems AB.