St. Jude Medical has received CE mark approval for its PressureWire X Guidewire fractional flow reserve (FFR) measurement system.
The system has been developed to identify the severity of narrowings in the coronary arteries of patients with coronary artery disease (CAD).
PressureWire FFR guidewire measurement is said to support more accurate lesion assessment during percutaneous coronary intervention (PCI) to enable physicians make informed treatment decisions for their patients.
Physicians can shape and reshape the tip of the new PressureWire X guidewire to assess multiple lesions in patients with complex anatomy.
The company’s fractional flow reserve versus angiography in multivessel evaluation (FAME) trials demonstrated that PressureWire technology can improve patient outcomes over angiography alone in patients with CAD.
St. Jude Medical global medical affairs vice president and chief medical officer Mark Carlson said: "St. Jude Medical strives to provide physicians with fractional flow reserve pressure guidewire options that are backed by clinical data and match the handling performance of conventional workhorse PCI guidewires, which is a combination that we have always prioritized in designing and developing the PressureWire series of FFR guidewires."
The company said the PressureWire X guidewire European launch will include a measured rollout to targeted countries throughout this year.