St. Jude Medical Announces FDA Approvals of New Pacemakers

  St. Jude Medical Announces FDA Approvals of New Pacemakers

First pacemaker with quadripolar technology now available in the U.S.

Business Wire

ST. PAUL, Minn. -- March 24, 2014

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced approval from the U.S. Food and Drug Administration (FDA) for the
Allure Quadra^™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which
provides additional pacing innovations for physicians to treat patients with
heart failure. The company also announced FDA approvals for the Assurity^™
pacemaker and Endurity^™ pacemaker families of devices.

The Allure Quadra (TM) Cardiac Resynchronization Therapy Pacemaker (CRT-P)
from St. Jude Medical, In ...

The Allure Quadra (TM) Cardiac Resynchronization Therapy Pacemaker (CRT-P)
from St. Jude Medical, Inc. (Photo: Business Wire).

“St. Jude Medical is the leader in quadripolar pacing technology, provided in
our high voltage CRT-D devices since 2009. In International markets where the
Allure Quadra CRT pacemaker is available, we experience strong demand and
significant share capture as the technology has become the standard of care
for many physicians,” said Eric S. Fain, M.D., group president at St. Jude
Medical. “Through product offerings like the Allure Quadra CRT-P and the
Assurity and Endurity pacemakers, we continue to deliver innovation through a
full continuum of pacemaker options.”

Allure Quadra CRT-P

The Allure Quadra CRT-P system brings quadripolar lead technology to the U.S.
pacemaker market for the first time. Quadripolar technology facilitates
additional pacing configurations within the heart that offer physicians
options not available in traditional bipolar systems. These additional options
help physicians to manage common pacing complications without exposing the
patient to additional surgeries for lead repositioning. To date, more than 100
clinical publications have provided broad clinical evidence in support of the
advantages of quadripolar technology from St. Jude Medical.

The Allure family of devices also offers enhanced heart failure (HF)
diagnostics that can help with patient monitoring and offer insights into
disease progression and management. Device information from the Allure Quadra
CRT-P is automatically transmitted to the secure St. Jude Medical website,
Merlin.net^™ Patient Care Network (PCN) as well as to the patient’s electronic
health record, where the information can be viewed by medical professionals.

“Adding the clinical benefits of quadripolar technology to pacemakers will
expand the benefits of this therapy to patients. These features and additional
pacing options will allow me to provide better care to patients diagnosed with
heart failure and reduce the need for repeat procedures, especially for those
patients who have been historically hard to treat due to tissue damage in
their heart.,” said Dr. Raffaele Corbisiero, chair of electrophysiology and
pacing and director of the Electromechanical Therapy Institute at the Deborah
Heart and Lung Center in Browns Mills, N.J. “This could have economic benefits
as well due to fewer readmissions for heart failure-related events.”

Assurity and Endurity Pacemakers

The Assurity and Endurity pacemakers are designed for longevity and feature a
smaller, physician-inspired shape, early notification of atrial
fibrillation-related events and pacing that helps reduce HF-related
hospitalizations^1. Available as a single or dual chamber pacemaker (pacing
either one or both chambers of the heart), both pacemakers provide a higher
level of care at implant and through patient’s lives. The Assurity pacemaker
uses RF technology to automatically transmit device data to a physician or
care team without any action by the patient. The Endurity pacemaker uses
inductive telemetry to rapidly provide device data during interrogation. Both
pacemakers are supported by the Merlin.net^™ Patient Care Network (PCN)
website for remote patient management.

The Allure Quadra CRT-P and the Assurity and Endurity pacemakers received CE
Mark in March 2013. St. Jude Medical intends to launch these products in the
U.S. by the end of the first quarter in 2014.

About Heart Failure

More than 5 million Americans have heart failure (HF) with 670,000 new cases
diagnosed each year. Roughly 1.4 million patients in the U.S. have NYHA Class
III HF, and historically these patients account for nearly half of all HF
hospitalizations. According to the American Heart Association, the estimated
direct and indirect cost of HF in the U.S. for 2012 was $31 billion and that
number is expected to more than double by 2030.

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.

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,
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 December 28, 2013. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.

^1. Faulknier B, Richards, M. (2012, Dec. 4-7). The Association of the Use of
the Ventricular Intrinsic Preference (VIP^™) Feature with Heart Failure
Hospitalization in Pacemaker Patients. Paper presented at the XV International
Symposium on Progress in Clinical Pacing, Rome, Italy.

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Contact:

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Sarah Shamla, 651-756-6293
Media Relations
sshamla@sjm.com
 
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