St. Jude Medical Launches Global Clinical Trial to Evaluate a New Therapy Option for Patients at an Increased Risk of Stroke Due to Atrial Fibrillation

The AMPLATZER™ Amulet™ IDE trial will expand access to the AMPLATZER™
Amulet™ Left Atrial Appendage Occluder to patients in the United States
who are in need of LAA closure to reduce their risk of stroke


ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the start of the St. Jude Medical AMPLATZER™ Amulet™ IDE
trial, which will evaluate the safety and effectiveness of the company’s
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder used to close the left
atrial appendage (LAA) in patients diagnosed with non-valvular atrial
fibrillation (AF). The first implant of the study took place at North
Mississippi Medical Center in Tupelo, Mississippi by Dr. Jim Stone.

In most people, the LAA — a small appendage connected to the left atrium
— does not increase the risk of adverse health effects, but in some
patients with atrial fibrillation, the LAA does not contract effectively
and it can become a source of blood clots. These clots can then be
released into the heart and enter the bloodstream, where they can travel
to the brain and cause a stroke. Currently, patients with AF at risk of
stroke are often prescribed blood-thinning medication, but this
treatment approach comes with a lifetime of medical management and the
risk of major bleeding. By closing the LAA with the AMPLATZER Amulet
occluder, physicians can “seal off” the LAA and potentially reduce the
risk of stroke.

The AMPLATZER Amulet occluder works by blocking the LAA at its opening,
which minimizes the opportunity for blood clots to form in the LAA and
migrate into the bloodstream. The AMPLATZER Amulet occluder, the
second-generation St. Jude Medical LAA occlusion device, is built with a
longer lobe and waist than the previous version and designed to allow
for easier and more stable placement, which could result in shorter
procedure times for patients. The AMPLATZER Amulet device is also
offered in eight sizes to accommodate varying anatomies.

“There’s a real need within the United States medical community for a
left atrial appendage occluder that addresses a wider range of complex
patient anatomies,” said Dr. Dhanunjaya Lakkireddy, Professor of
Medicine and the Director of the Center for Excellence in Atrial
Fibrillation and Complex Arrhythmias at the University of Kansas. “The
Amulet device has been used successfully in Europe, and I see this IDE
trial as the right step toward providing patients with atrial
fibrillation the optimal level of care to further reduce the risk of
stroke.”

The AMPLATZER Amulet IDE trial is a randomized trial, which will enroll
patients at up to 100 sites in the United States and an additional 50
sites internationally. Patients enrolled in the AMPLATZER Amulet IDE
trial will be randomly assigned to receive either the St. Jude Medical
Amulet device or an FDA approved LAA closure device in the control arm
of the study. Data collected across all trial sites will be used to
support FDA approval of the AMPLATZER Amulet Occluder.

“The AMPLATZER Amulet device, which is the current market leader among
left atrial appendage occluders in Europe, was developed to provide
physicians additional treatment options to improve patient care,” said
Mark Carlson, M.D., chief medical officer and vice president of medical
affairs at St. Jude Medical. “Enrollment in the AMPLATZER Amulet IDE
trial will take us one step closer to bringing this important technology
to patients in the United States who are at an increased risk of stroke
due to atrial fibrillation.”

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. Approximately 87 percent of all
strokes are ischemic, which occur when blood clots block the blood
vessels to the brain. Stroke is the third leading cause of death and the
No. 1 cause of long-term disability. AF is responsible for approximately 20
percent
of ischemic strokes and about one-third
of AF patients will have a stroke in their lifetime if not treated
appropriately.

The AMPLATZER Amulet Left Atrial Appendage Occluder is CE Mark approved
and available in Europe.

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, 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.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor
Relations
jweigelt@sjm.com
or
Laurel
Hood, 651-756-2853
Media Relations
LHood02@sjm.com