FDA clears guidewire FFR measurement system for use in PCI procedures

The FDA has cleared the PressureWire X guidewire fractional flow reserve (FFR) measurement system for use in patients undergoing PCI.

Physicians use the system to identify the severity of narrowings in the coronary arteries, according to a St. Jude Medical news release. St. Jude Medical, the St. Paul, Minnesota-based manufacturer of the system, said it is now available in the U.S.

The company has also launched a multicenter trial to assess FFR-guided PCI in patients with acute coronary syndromes. Approximately 20 percent of PCI procedures in the U.S. use FFR guidance.