FDA clears St. Jude's latest FFR-measuring guidewire for coronary artery disease

PressureWire X Guidewire--Courtesy of St. Jude Medical

Correction: This story has been updated to reflect the number of PCI procedures that use FFR measurements. It is 20%, or "one in five," and not five out of 900,000 as previously stated.

St. Jude Medical launched its newly FDA-cleared guidewire that measures fractional flow reserve. It is designed to improve percutaneous coronary intervention procedures in patients with narrowed coronary arteries.

PCI, also known as coronary angioplasty, is a nonsurgical procedure that treats narrowed arteries by inflating a balloon catheter and possibly placing a stent or scaffold in the affected artery.

St. Jude’s PressureWire X GuideWire FFR system provides physicians with fractional flow reserve measurements, helping them gauge how severely narrowed a patient’s arteries are, the company said in a statement. The latest iteration of the PressureWire family, it is designed to cut down on vessel trauma, making it suitable for use in patients with complex anatomies. Interventional cardiologists can use FFR values to decide which lesions, or narrowed areas, need stenting. This can result in more accurate diagnoses and better treatment decisions, St. Jude said.

“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,” said Dr. Annapoorna Kini, the director of the cardiac cath lab and the director of the interventional fellowship program at Mount Sinai Medical Center, in the statement. “The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”

Although there is strong evidence backing the utility of FFR in PCI procedures, only 20% of the more than 900,000 procedures performed each year in the U.S. are guided by FFR. The PressureWire system was found to improve outcomes compared with angiography alone in patients with coronary heart disease. St. Jude has also initiated a study to examine the clinical outcomes of FFR-guided PCI procedures in patients with acute coronary syndrome.