St. Jude Medical Announces First Patient Enrollment in EnligHTN II Renal Denervation Study

  St. Jude Medical Announces First Patient Enrollment in EnligHTN II Renal
  Denervation Study

Company expands evaluation of its EnligHTN renal denervation technology for
hypertension to new patient populations

Business Wire

ST. PAUL, Minn. -- January 30, 2013

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced enrollment of the first patient in the EnligHTN II trial. This
post-market clinical study will further evaluate the safety and efficacy of
the EnligHTN^™ Renal Denervation System in patients with uncontrolled
hypertension. According to the World Health Organization (WHO), one in three
adults worldwide has elevated blood pressure - a condition that increases the
risk of heart attack, stroke and kidney failure.

The EnligHTN Renal Denervation System from St. Jude Medical. (Photo: Business

The EnligHTN Renal Denervation System from St. Jude Medical. (Photo: Business

The EnligHTN II (IntErnational non-randomized, single-arm, long-term follow-up
study of patients with uncontrolled HyperTensioN) trial expands upon the
research conducted in the EnligHTN I trial, which demonstrated that patients
with drug-resistant hypertension treated with the St. Jude Medical EnligHTN
system had a rapid and sustained drop in blood pressure. After thirty days,
systolic blood pressure was reduced by an average of 28 mmHg that remained
stable with a reduction of 26 mmHg points six months after treatment, an
important finding as the risk of cardiovascular death drops by half with every
systolic decrease of 20 mmHg.

“There is convincing evidence from studies like the EnligHTN I trial linking
renal denervation to improved blood pressure in patients who have
drug-resistant hypertension,” said Dr. Johannes Brachmann at Klinikum Coburg
in Coburg, Germany. “Expanding this research to patients with less severe
forms of hypertension is important as this minimally invasive approach allows
for a shorter procedure time and a potentially faster recovery time, which may
benefit more patients with uncontrolled hypertension.”

Hypertension occurs when blood pressure in the arteries is elevated, requiring
the heart to work harder than normal to circulate blood throughout the body. A
typical normal blood pressure reading is below 120 systolic and 80 diastolic –
expressed as 120 / 80 mmHg. To date, the majority of renal denervation studies
have only tested the safety and efficacy of this technology in patients with
drug-resistant hypertension, which is defined as systolic blood pressure
above160 mmHg, despite being on three or more anti-hypertensive medications
including a diuretic.

The EnligHTN II study aims to broaden this scope by evaluating the mean
reduction in systolic blood pressure at six months across all enrolled
patients post renal denervation and within sub-groups with varying degrees of
kidney functionality. The study will be conducted at 40 sites in Europe and
Australia and will enroll approximately 500 patients with uncontrolled

“St. Jude Medical is dedicated to conducting research that will contribute to
the body of evidence supporting the effectiveness of renal denervation in
reducing hypertension,” said Frank J. Callaghan, president of the St. Jude
Medical Cardiovascular and Ablation Technologies Division. “Through the course
of the EnligHTN II study, we expect to gain additional insights into the
benefits and sustainability of blood pressure reductions achieved through use
of the EnligHTN Renal Denervation System in an expanded patient population.”

About Renal Denervation and the EnligHTN System

Renal denervation is a catheter-based ablation procedure that potentially
provides lasting reduction in blood pressure for patients with resistant
hypertension. A catheter is introduced through the femoral artery in the leg
to access the renal arteries that connect to the kidneys, where radiofrequency
(RF) energy is delivered to create lesions (tiny scars) along the renal
sympathetic nerves – a network of nerves that help control blood pressure.
This intentional disruption of the nerve supply causes systolic and diastolic
blood pressure to decrease.

The EnligHTN system is a multi-electrode ablation technology that features a
unique, non-occlusive basket design that delivers a predictable pattern of
four evenly-spaced ablations with each catheter placement. This allows for
continuous blood flow to the kidney during the procedure. Compared to
single-electrode ablation systems, the multi-electrode EnligHTN system has the
potential to improve consistency and save time, which may result in improved
workflow and cost efficiencies.

The renal denervation technology includes a guiding catheter, ablation
catheter and ablation generator. The generator uses a proprietary,
temperature-controlled algorithm to produce effective lesions. Additionally,
minimal catheter repositioning may result in a reduction of contrast and
fluoroscopic (X-ray) exposure.

In 2012, The EnligHTN Renal Denervation System earned European CE Mark
approval and was launched in several markets. It is not yet approved for use
in the U.S.

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

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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St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
Denise Landry, 972-309-8085
U.S. Media Relations
Marisa Bluestone, 651-756-6739
International Media Relations
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