ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced new results from two clinical studies further supporting the use of St. Jude Medical fractional flow reserve (FFR) technology to optimize percutaneous coronary intervention (PCI) procedures used to restore blood flow to the heart. The studies – a 15-year follow-up to the DEFER study and primary results from the CONTRAST study – were presented earlier today during hotline sessions at EuroPCR 2015. Combined, the studies contribute to the growing body of evidence supporting FFR as a valuable and important decision-making tool for physicians.
Coronary artery disease (CAD) is the most common type of heart disease, and affects millions of people worldwide. The condition is caused by a narrowing or blocking of the arteries due to plaque which restricts blood flow, and reduces the amount of oxygen to the heart. Physicians often use angioplasty, or PCI, to treat narrowed vessels and restore blood flow to the heart.
St. Jude Medical’s PressureWire™ FFR technology supports better treatment decisions for patients by providing a more detailed, physiologic analysis of blood flow blockages in the heart. Specifically, FFR can help accurately identify which coronary lesions or blockages are responsible for obstructing the flow of blood to a patient’s heart muscle. This insight allows physicians to determine which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs.
The DEFER Study: Demonstrating sustained benefits of FFR guidance after 15 years
In a 15-year follow up study, new data from the DEFER study confirms original and five-year findings. Researchers leading the DEFER study found the positive benefits of decisions based on St. Jude Medical PressureWire FFR guidance were sustained after 15 years. The study also found the risk for a myocardial infarction was 6.5 times lower in patients where treatment was guided by FFR compared to patients in the non-FFR guided group, while finding no negative effect of leaving non-significant lesions untreated.
The DEFER study’s 15 year data is an important advancement of FFR, because it confirms sustained benefits of FFR guidance over time. After 15 years, DEFER researchers found stenting a non-ischemic stenosis, or narrowing of the blood vessel restricting blood flow to the heart, had no benefit compared to patients treated by standard medical therapy. In addition to a reduction in heart attacks, patients where revascularization was deferred had very low rates of complications compared to patients in which lesions were treated without proof of ischemia.
“We are pleased to see the sustained benefits of this study over 15 years. We also find it quite important that there were no myocardial infarctions as a result of deferring non-significant lesions, based upon FFR guidance,” said original DEFER investigator Nico Pijls, M.D., Ph.D., of the Catharina Hospital in Eindhoven, the Netherlands. “This study confirms the long-term importance of using FFR to guide PCI and improve the outcome of stenting.”
The CONTRAST Study: Simplifying lesion assessment without sacrificing accuracy
In the CONTRAST study, researchers assessed FFR differently, and compared the gold standard in vascular physiologic assessment, FFR using adenosine, to resting indices (Pd/Pa and iFR) and a new approach to adenosine-free FFR; FFR using contrast medium. Contrast FFR (cFFR), also known as contrast Pd/Pa, is a new diagnostic approach where the hyperemic effect (an increase in blood flow) is induced by contrast medium in place of adenosine.
The study found that cFFR provides superior accuracy compared to resting indices such as iFR or resting Pd/Pa. To date, simplifying physiologic assessment using resting indices has resulted in a reduction in accuracy, which has limited adoption. The CONTRAST study found both Pd/Pa and iFR to offer similar rates of accuracy. In addition, the study’s researchers concluded cFFR did not add extra cost or procedure time and may be a viable option for situations where the use of adenosine is undesired or contra indicated.
“Building upon the strong legacy of landmark evidence supporting FFR, the DEFER and CONTRAST studies are another important step forward as St. Jude Medical collaborates with physicians to generate a robust pool of data supporting FFR as a clinical tool that can positively impact patient care,” said Mark Carlson, M.D., chief medical officer at St. Jude Medical.
About Fractional Flow Reserve (FFR)
FFR is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire™ Aeris and PressureWire™ Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer 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 has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.