New Data Presented at EuroPCR 2016 Adds to the Growing Body of Clinical Evidence Supporting St. Jude Medical FFR Technology and LAA Closure
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from two cardiovascular clinical trials presented at EuroPCR 2016. The studies, which include a look at how St. Jude Medical™ fractional flow reserve (FFR) technology impacts patient outcomes in Acute Coronary Syndrome (ACS) and a comparison of left atrial appendage occlusion (LAAO) therapy to standard medical treatment – were presented during hotline sessions.
The latest studies contribute to the growing body of evidence supporting two important St. Jude Medical cardiovascular therapies: FFR guidance with St. Jude Medical PressureWire™ technology to optimize percutaneous coronary intervention (PCI) procedures in patients with narrowed or blocked coronary arteries, as well as left atrial appendage closure for patients at increased risk of stroke as a result of atrial fibrillation. St. Jude Medical has been an international leader in LAAO therapy, originally offering the AMPLATZER™ Cardiac Plug (ACP) for LAAO and now offering the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder.
PRIME-FFR Study showcases the benefits of FFR in the Treatment of ACS
Presented today at a EuroPCR Hotline session, the PRIME-FFR study aimed to quantify the value of FFR when deciding the most appropriate treatment for patients with ACS. In the medical community, ACS is an umbrella term for medical conditions where blood supply to the heart is suddenly blocked. According to the American Heart Association, the blockage can be sudden and clog the entire artery or it can be a moving clot that causes temporary blockage and decreased blood supply. The condition is more commonly referred to as a heart attack and needs to be addressed by a physician immediately.
In assessing the value of FFR, the study’s investigators defined management strategies for patients based on angiography results before performing FFR, and then made a final treatment strategy decision after performing FFR. Results showed that management strategy reclassification after performing routine FFR was high and that FFR is safe to use in ACS patients, indicating a management strategy guided by FFR safely leads to changes in physician decision making.
“These data further support the benefits of the St. Jude Medical fractional flow reserve portfolio and show that using our fractional flow reserve technology as part of a management plan helps physicians make informed treatment decisions,” said Dr. Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude Medical. “We are committed to providing the best treatment options for our patients and technology like this allows us to do so.”
Assessing the impact of St. Jude Medical’s LAAO technology versus standard medical therapy in patients with atrial fibrillation and intracerebral hemorrhage
In a hotline presentation at EuroPCR, researchers assessed the impact of a LAAO in patients with atrial fibrillation (AF) and intracerebral hemorrhage (ICH) versus patients who received standard medical therapy. The left atrial appendage (LAA) is a small pouch that hangs from the left atrium, which is considered to be unproblematic for most people with a regular heart rhythm. However, patients with AF experience a chaotic, uncontrolled heart rhythm, which can increase the likelihood of clot formation in the LAA, potentially resulting in a stroke. Because AF leads to an increased risk of stroke, a physician may seal off the LAA with an LAA Occluder, or prescribe oral anticoagulants (OAC) to potentially reducing that risk.
While OACs are proven to be effective in reducing the risk of stroke in patients with AF, this therapy carries the risk of ICH, or recurrent bleeding, which is the leading cause of stroke mortality. Because the risk of reoccurring ICH is increased among patients who have previously experienced an ICH, many of these patients are denied OAC.
The LAAO in AF and ICH study found that patients with AF and a prior ICH who were treated with a St. Jude Medical LAAO device had a lower risk of ischemic stroke, major bleeding and all-cause mortality compared to patients treated with standard care, suggesting that LAAO offers a major clinical benefit.
“Patients with atrial fibrillation and previous intracerebral hemorrhage have an increased risk of ischemic stroke or repeated hemorrhage,” said Jens Erik Nielsen-Kudsk, M.D., DMSc, an associate professor of cardiologic medicine at Aarhus University and the study’s lead author. “The data from the this latest clinical assessment further shows that having a device like the AMPLATZER LAA occlusion device implanted in these patients’ hearts offers them additional opportunity for improved cardiac health.”
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 .
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.
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