St. Jude Medical Announces First Implant Evaluating New Size of Portico Heart Valve in Ongoing European Clinical Trial

  St. Jude Medical Announces First Implant Evaluating New Size of Portico
  Heart Valve in Ongoing European Clinical Trial

Business Wire

ST. PAUL, Minn. -- February 4, 2013

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced the first patient implant of its 25 mm Portico^™ Transcatheter
Aortic Heart Valve using the Transfemoral Delivery System in its ongoing
European trial. The Portico valve system offers a minimally invasive treatment
option for patients with severe aortic stenosis – a narrowing of the aortic
valve that obstructs blood flow from the heart.

25 mm Portico(TM) Transcatheter Aortic Heart Valve (Photo: St. Jude Medical)

25 mm Portico(TM) Transcatheter Aortic Heart Valve (Photo: St. Jude Medical)

The Portico Transfemoral European Trial (Portico TF EU Trial) was established
to evaluate the 23 mm Portico valve, which recently received European
approval, and has been expanded to include the 25 mm Portico^™ valve.

A non-randomized, multi-center study, the Portico TF EU Trial will evaluate
the safety and performance of the Portico 25 mm transcatheter heart valve in
patients with severe aortic stenosis. The trial will enroll up to 50 patients
across Europe. Data from the study will be used to support CE Mark approval.

Expanding the Portico TF EU trial to include the 25 mm Portico valve size
allows physicians to increase their research of the technology in patients
whose anatomy requires a larger valve size.

Made of bovine pericardial tissue, the Portico valve is attached to a
self-expanding stent frame. It is the only approved transcatheter valve that
can be completely resheathed (the process of bringing the valve back into the
delivery catheter), repositioned at the implant site, or retrieved before
being released from the delivery system.

Transcatheter heart valves like Portico are used to treat patients with severe
aortic stenosis. These patients often are too sick and have co-morbidities
that prevent them from having conventional open-heart valve replacement
surgery. The Portico valve helps to restore normal blood flow and provides an
innovative and life-saving treatment option.

During a transcatheter procedure using the transfemoral delivery system, a
physician implants the Portico valve through a catheter which has been placed
through a small incision in the artery of the leg in order to gain access to
the heart.

“The start of the Portico TF EU Trial for the 25 mm Portico valve is another
major milestone in our transcatheter valve program and an indication of our
commitment to provide new options to patients suffering from aortic valvular
heart disease,” said Frank J. Callaghan, president of the Cardiovascular and
Ablation Technologies Division at St. Jude Medical.

The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System
are not yet approved for use in the United States. A U.S. clinical trial
evaluating the Portico valve is expected to start later this year. The trial
will be conducted under a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE).

It is estimated that as many as 400,000 people worldwide are affected by
severe aortic stenosis, a potentially life-threatening condition where the
aortic heart valve becomes calcified and does not open widely enough.

For additional information about the Portico valve visit SJMPortico.com.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on
putting more control into the hands of those who treat cardiac, neurological
and chronic pain patients worldwide. The company is dedicated to advancing the
practice of medicine by reducing risk wherever possible and contributing to
successful outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include: cardiac rhythm
management, atrial fibrillation, cardiovascular and neuromodulation. For more
information, please visit sjm.com.

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 31, 2011 and Quarterly
Report on Form 10-Q for the fiscal quarter ended September 29, 2012. 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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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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