CE Mark Approval for St. Jude Medical's PressureWire X Guidewire FFR Measurement System

May 18, 2016—St. Jude Medical, Inc. announced CE Mark approval and the European launch of its PressureWire X guidewire fractional flow reserve (FFR) measurement system. The company introduced the device at the EuroPCR 2016 conference held May 17–20 in Paris, France. The European launch of the PressureWire X guidewire will include a measured rollout to targeted countries throughout 2016.

According to St. Jude Medical, 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 coronary artery disease. Additionally, 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, leading to improved patient outcomes.

The device is designed to provide better durability and shape retention than currently available pressure guidewires, with a tip that can be shaped and reshaped during PCI, which enables it to be used to assess multiple lesions, even in patients with complex anatomy. With the ability to better navigate each patient’s unique anatomy, physicians can more accurately assess and diagnosis coronary blockages, which can lead to more informed decision making on how best to restore blood flow to the heart. The latest PressureWire X guidewire is also designed to support faster procedure times, ensuring patients undergo more efficient PCI procedures, stated St. Jude Medical.

In the company’s press release, Bernard De Bruyne, MD, of the CVC Aalst, Belgium commented, “FFR 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 FFR procedure by enabling access to lesions in patients with tortuous, complex anatomy.”