"Patients with atrial fibrillation at risk of stroke are usually prescribed anticoagulant medication, but this treatment comes with some limitations. Patients might not tolerate the medication, plus there's a risk for major bleeding," said Dr. David Hildick-Smith from Sussex Cardiac Centre at Brighton and Sussex University Hospitals Brighton, United Kingdom and principal investigator of the AMPLATZER Amulet Observational Study. "By closing the LAA with the AMPLATZER Amulet device, physicians can seal off the LAA, with the objective of reducing the risk of stroke and eliminating the need for oral anticoagulants."Other key findings of the Amulet Observational study include:
- Closure rate was 99 percent at one to three month follow-up visit (n=364). Closure was defined as absence of flow or flow of < 3 mm jet into the LAA. All echocardiography results were adjudicated by an independent core lab.
- Acute device/procedure related major adverse events within seven days post procedure occurred in 2.7 percent (29) of 1,073 patients.
The shape and size of an LAA can vary greatly. The AMPLATZER Amulet LAA Occluder has a conformable disc and lobe designed for complete occlusion of the LAA and offers the broadest size range available. The device offers physicians options to help meet the anatomical demands of patients in need of LAA closure.About Atrial Fibrillation and Stroke During AF, chaotic electrical signals in the heart's upper chambers (atria) beat erratically and out of sync with the two lower chambers, resulting in poor blood flow. The LAA is a tube-shaped appendage connected to the left atrium of the heart that can potentially hold static blood during an episode of AF, increasing the likelihood of clot formation. Research shows that in AF patients, approximately 90 percent of all cardiac blood clots form in the LAA. If a clot forms in the LAA and is then released into the heart, it may enter blood circulation, travel to the brain, block a vessel and cause an ischemic stroke. The current standard of care to treat ischemic stroke in AF patients is blood-thinning medications, which comes with major, sometimes fatal, bleeding risks. According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the United States an estimated $53.9 billion in health care services, medications and missed days of work. 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 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, reimbursement strategies, 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 July 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.