St. Jude Medical Launches PressureWire Guidewire Technology in Europe

St. Jude Medical Inc. has received CE Mark approval and launched in Europe 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 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 Dr. Bernard De Bruyne of the CVC Aalst in 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 optimize 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 trails 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 multicenter 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.
 
“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,” said Dr. Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude Medical. “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.”
 
The original St. Jude Medical sponsored FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial compared outcomes of patients whose treatment was guided by FFR to those whose treatment was only guided by angiography. Results from the landmark trial demonstrated improved clinical outcomes in patients with stable coronary artery disease and two or three vessel disease.
 
The 12-month results demonstrated that instances of major adverse cardiac events were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Two-year results demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction in death or heart attack.
 
FFR is an index determining the functional severity of narrowings in the coronary arteries, and it is measured by PressureWire Aeris or PressureWire Certus FFR measurement system. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients’ heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.
 
Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular.