FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Launch of PressureWire X Guidewire

Oct. 11, 2016

St. Jude Medical gained marketing clearance from the FDA and promptly launched its PressureWire X Guidewire fractional flow reserve (FFR) measurement system.

The device is designed to improve structure and shape retention to reduce vessel trauma during percutaneous coronary intervention (PCI) and procedures involving complex anatomies.

There are nearly 900,000 PCI procedures performed in the U.S. each year. — Cynthia Jessup

View today's stories