|[October 28, 2013]
New Data from St. Jude Medical Study of EnligHTN Renal Denervation System Presented Today at Scientific Symposium
ST. PAUL, Minn. --(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced new results from the EnligHTN I study, confirming safe,
rapid and sustained reduction in blood pressure measurements a year and
a half post-procedure. Data presented at the 25th annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium,
indicates that patients with drug-resistant hypertension treated with
the EnligHTN™ Multi-Electrode Renal Denervation System
averaged a 24 mmHg (millimeters of mercury) reduction in systolic blood
pressure as measured in an office setting.
The EnligHTN (TM) Multi-Electrode Renal Denervation System from St. Jude Medical, Inc. The EnligHTN system is not approved for use in the U.S. (Photo: Business Wire)
"Convincing clinical evidence continues to emerge that supports the
benefits of renal denervation in improving systolic blood pressure for
patients with drug-resistant hypertension," said professor Stephen
Worthley, from St. Andrew's Hospital in Adelaide, Australia, a primary
investigator in the EnligHTN I trial, who delivered the findings at TCT.
"The 18-month results of the EnligHTN I study point to an overall
reduction in hypertension, which is important as even modest
improvements can have significant health benefits for patients who live
with this life-threatening condition. This also supports that the early
reduction in blood pressure remains sustained out to 18-months,
confirming the durability of this procedure using the EnligHTN catheter."
Eighteen-Month Data Findings:
An average systolic blood pressure reduction of 24 mmHg points was
The longer-term safety profile for renal denervation was supported by
showing no clinically significant changes in kidney function
At 18-months, 77 percent of patients responded to the therapy, which
is defined as a blood pressure reduction of at least 10 mmHg when
measured during an office visit as compared to baseline
A prospective, multi-center feasibility study, the EnligHTN
I trial treated 46 patients in Australia and Europe whose high blood
pressure was considered drug-resistant despite taking three or more
anti-hypertensive medications including a diuretic. Patients enrolled in
the study had an average blood pressure of 176 / 96 mmHg and on average
were taking 4.7 medications to control their hypertension. Patients in
the study will continue to be followed for two years after their
Previous results from the EnligHTN I trial indicate an average reduction
of 26 mmHg at six-months, 27 mmHg at one year and 24 mmHg at 18-months.
"St. Jude Medical has invested in a robust clinical program to build the
body of clinical evidence intended to support renal denervation as the
standard of care for the treatment of drug-resistant hypertension," said
Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and
Ablation Technologies Division. "These new data from our first renal
denervation study demonstrate this therapy is durable and can benefit
patients struggling to control their hypertension."
Renal Denervation and the EnligHTN System
The EnligHTN system is a multi-electrode ablation technology for renal
denervation, a minimally invasive procedure to treat patients with
drug-resistant hypertension. The system delivers a series of
radiofrequency (RF) energy ablations to create lesions (tiny scars)
along the renal sympathetic nerves - a network of nerves leading to the
kidneys that help control blood pressure. A normal blood pressure is
typically at o below 120 systolic and 80 diastolic, which is expressed
as 120 / 80 mmHg. Hypertension is categorized as a blood pressure
reading greater than 140 / 90 mmHg. The risk of cardiovascular death is
cut in half with every 20 mmHg decrease in systolic blood pressure.
Compared to single-electrode ablation systems, the non-occlusive basket
design of the multi-electrode EnligHTN system has the potential to
improve procedural accuracy, save time as well as result in workflow and
cost efficiencies. This also allows for continuous blood flow to the
kidney during the procedure.
In May 2012, the first-generation EnligHTN Multi-Electrode Renal
Denervation System earned European
CE Mark approval and was launched in several markets. The company
also announced CE Mark approval of the next-generation EnligHTN system
2013. Featuring an advanced generator, the next-generation system delivers
simultaneous ablations via the multi-electrode catheter, reducing
total ablation time by more than 80 percent, from approximately 24
minutes to four minutes. The EnligHTN systems are not yet approved for
use in the U.S.
St. Jude Medical is conducting multiple renal
denervation studies to add to the body of evidence supporting the
potential of renal denervation therapy. In June
2013, the company announced the FDA approval to start a U.S.
clinical trial, EnligHTN
IV, evaluating the use of the EnligHTN Multi-Electrode Renal
Denervation System to treat 590 patients at up to 80 sites across the
U.S. and Canada with drug-resistant high blood pressure. The EnligHTN IV
trial is now enrolling patients in the U.S.
Earlier this year, the company announced the EnligHTNment
trial. This landmark study is the first large-scale trial designed
with hard endpoints that will evaluate the long-term effects of renal
denervation to see if the therapy also reduces the risk of heart attack,
stroke, heart failure requiring hospitalization, as well as
cardiovascular death in patients with uncontrolled or resistant
According to the World
Heart Federation, one billion people globally have high blood
pressure which occurs when blood pressure in the arteries is elevated,
requiring the heart to work harder to circulate blood throughout the
body. Hypertension is referred to as a "silent killer" because it
presents no warning signs or symptoms and oftentimes people do not
realize they have it.
Society of Cardiology (ESC) and the European Association of Percutaneous
Cardiovascular Interventions (EAPCI) recently issued guidelines
recommending the use of catheter-based renal denervation for the
treatment of high blood pressure in patients with difficult-to-treat,
To learn more about renal denervation or view the EnligHTN
Multi-Electrode Renal Denervation System, TCT attendees can visit St.
Jude Medical at booth #617.
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 (News - Alert) @SJM_Media.
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 (News - Alert), 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 29, 2012 and Quarterly Report on
Form 10-Q for the fiscal quarter ended June 29, 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.
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