The US Food and Drug Administration (FDA) has approved St. Jude Medical's new PressureWire X guidewire fractional flow reserve (FFR) measurement system.

The system has been designed to enhance percutaneous coronary intervention (PCI) procedures in patients with complex anatomies.

A PCI procedure is a non-surgical procedure, which will involve the opening of coronary blood flow blockages and restore blood flow to the hearts of patients living with coronary artery disease (CAD).

PressureWire X guidewire will enable physicians to identify the severity of narrowings in the coronary arteries.

The firm has also launched PRESSUREwire registry (practical evaluation of fractional flow reserve (FFR) and its association alternate indices during routine clinical procedures) multicenter clinical trial to specify the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome (ACS.

PRESSUREwire registry will be based on clinical trials that are designed to assess the positive outcomes associated with FFR technology.

The trials include the St. Jude Medical sponsored FAME (fractional flow reserve (FFR) vs.angiography in multivessel evaluation) trials, which showed PressureWire guidewire technology can improve patient outcomes over angiography alone in patients with CAD.

St. Jude Medical global medical affairs vice president and chief medical officer Dr Mark Carlson said: “St. Jude Medical strives to provide physicians with fractional flow reserve pressure guidewire technology that is backed by ample clinical data and that matches the handling performance of conventional PCI guidewires.

“The new PressureWire X Guidewire shows our dedication to providing physicians with cost-effective, easy-to-use technologies that aid them in making the best treatment decisions for their patients.”

Image: St. Jude Medical PressureWire X guidewire fractional flow reserve measurement system. Photo: courtesy of Business Wire.