St Jude Medical has announced CE mark approval and European launch of the PressureWire X Guidewire fractional flow reserve (FFR) Measurement System. 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), resulting in more accurate diagnosis. The company will showcase the new PressureWire X guidewire technology at the EuroPCR 2016 meeting (17–20 May, Paris, France). The PressureWire X guidewire European launch will include a measured rollout to targeted countries throughout 2016.
PressureWire FFR guidewire measurement supports more accurate lesion assessment during percutaneous coronary intervention (PCI) to help physicians make more informed treatment decisions for their patients, which has been shown to improve patient outcomes. 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.
“Fractional flow reserve has become an indispensable tool for assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention,” said Bernard De Bruyne of the CVC Aalst, Belgium. “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.”
Designed to provide better durability and shape retention than currently available pressure guidewires, the new 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. Allowing physicians to better navigate each patient’s unique anatomy will support improved assessment and diagnosis of coronary blockages, which can lead to improved decision-making on how best to restore blood flow to the heart. The latest PressureWire X guidewire is also intended to support faster procedure times, ensuring patients undergo more efficient PCI procedures.
The use of FFR to optimise PCI is supported by strong evidence, such as the FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trials, which found that St Jude Medical PressureWire technology can improve patient outcomes over angiography alone in patients with CAD. 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.
In addition to clinical trials designed to assess the positive outcomes associated with FFR technology, St Jude Medical has launched the PRESSUREwire REGISTRY (Practical Evaluation of Fractional Flow Reserve (FFR) and its Association Alternate Indices During Routine Clinical Procedures), a multicentre clinical trial to determine the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome (ACS), a major cause of global morbidity and mortality.
