St. Jude Medical Presents New Data on AMPLATZER Amulet Left Atrial Appendage Occluder

- November 2nd, 2016

St. Jude Medical, a global medical device company, today presented favorable results from the largest observational study to date of the company’s AMPLATZER™ Amulet™ left atrial appendage occluder.

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today presented favorable results from the largest observational study to date of the company’s AMPLATZER™ Amulet™ left atrial appendage (LAA) occluder. The data were presented in a Late Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C.
The prospective, multicenter, international AMPLATZER Amulet
Observational Study of LAA occlusion (closure) enrolled 1,073 patients
at 64 centers across 18 countries. Initial results from the study showed
a 98.8 percent implant success rate adding to the clinical evidence that
the AMPLATZER Amulet LAA Occluder is a safe alternative for prevention
of stroke in patients with non-valvular atrial fibrillation (AF).
The AMPLATZER Amulet LAA Occluder is used to close the LAA (an appendage
of the left atrium) in patients diagnosed with non-valvular AF. Atrial
fibrillation occurs when the upper chambers of the heart (atria)
contract rapidly and irregularly, which can disrupt efficient pumping of
the blood out of the heart. Blood that pools in the atria can clot and,
if the clot moves to an artery in the brain, stroke may occur. Studies
have shown that AF can dramatically increase the risk of stroke for
patients and for many patients, medication has historically been the
option physicians turn to most often.
“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.

“Initial data from this large-scale observational study continue to
affirm the AMPLATZER Amulet LAA Occluder as an important treatment
option to reduce the risk of stroke in patients with non-valvular AF,”
said Dr. Srijoy Mahapatra, medical director and vice president of
medical affairs at St. Jude Medical. “The AMPLATZER Amulet Occluder has
favorable closure rates when compared to other device reports in a
similar patient group.”
The AMPLATZER Amulet Left Atrial Appendage Occluder is CE Mark approved,
but remains an investigational device in the United States. In
September, St. Jude Medical announced the start of the AMPLATZER™
Amulet™ LAA Occluder IDE trial, evaluating the safety and effectiveness
of the company’s AMPLATZER Amulet occluder device. The trial will enroll
patients at up to 100 sites in the United States and an additional 50
sites internationally.
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
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

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