St. Jude Medical Receives FDA Clearance for PressureWire X Guidewire FFR Measurement System

October 10, 2016—St. Jude Medical, Inc. announced that is has received US Food and Drug Administration 510(k) clearance for its PressureWire X guidewire fractional flow reserve (FFR) measurement system for use in percutaneous coronary intervention (PCI).

The company noted that the PressureWire X guidewire system is designed to offer improved shapeability and shape retention to reduce vessel trauma during PCI, especially in patients with complex anatomy.

In the company’s press release, Annapoorna Kini, MD, commented, “For years, clinical research has confirmed that fractional flow reserve is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention.” Dr. Annapoorna Kini is Director of the Cardiac Cath Lab and Interventional Fellowship Program at Mount Sinai Medical Center in New York, New York. He continued, “The improved design and shape retention of the new PressureWire X guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”

In May, St. Jude Medical announced that the PressureWire X guidewire system received CE Mark approval.