www.fdanews.com/articles/178791-fda-clears-launch-of-pressurewire-x-guidewire
FDA Clears Launch of PressureWire X Guidewire
October 10, 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