ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today 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, May 17-20, 2016 in Paris. 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, 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.”
About the Original FAME Trial
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 published in the New England Journal of Medicine 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.
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (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.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. 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. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2016. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
