Technology that measures artery narrowing receives CE mark

St. Jude Medical has announced the CE Mark approval and European launch of the PressureWire X Guidewire fractional flow reserve (FFR) Measurement System

The system is designed to identify the severity of narrowings in the coronary arteries of patients with coronary artery disease (CAD).

FFR measurement allows for a more effective assessment of coronary lesions (blockages). The company said that PressureWire FFR guidewire measurement supports accurate lesion assessment during percutaneous coronary intervention (PCI) to help physicians make more informed treatment decisions.

The newly launched PressureWire X guidewire offers enhanced durability and improved handling in either a cabled or wireless configuration, both with the accuracy and reliability physicians need when treating patients with CAD, according to St. Jude.

Bernard De Bruyne of the CVC Aalst, Belgium, said: “Fractional flow reserve has become an indispensable tool for assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention.

“The improved design of the new PressureWire X guidewire tip will simplify the fractional flow reserve procedure by enabling access to lesions in patients with tortuous, complex anatomy.”

The PressureWire X guidewire aims to provide physicians with a tip that can be shaped and re-shaped during PCI, which enables it to be used to assess multiple lesions, even in patients with complex anatomy, according to the company.

The use of FFR to optimise PCI is supported by the FAME trials, which found that St. Jude Medical PressureWire technology can improve patient outcomes over angiography alone in patients with CAD, St. Jude reported.

The FAME body of evidence also demonstrated reductions in the risk of death or heart attack in patients undergoing PCI, as well as reduced health care costs for patients whose treatment was guided by FFR technology.

Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude, 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 prioritised in designing and developing the PressureWire series of FFR guidewires.

“The new PressureWire X guidewire shows our dedication to providing physicians with cost-effective, easy-to-use technologies that aid them in making the best treatment decisions for their patients.”