St. Jude Medical, Inc. : Renal Denervation Technology from St. Jude Medical Demonstrates Significant Reduction in Blood Pressure
05/16/2012| 02:50am US/Eastern
Use of EnligHTN technology resulted in a 28 point reduction of systolic
blood pressure on average after 1 month
Trial showed double the reduction in blood pressure of competitive
technology in the same timeframe
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced that preliminary data demonstrated the company's
EnligHTN™ renal denervation system was safe and effective for the
treatment of resistant hypertension. The study demonstrated that on
average patients with resistant hypertension experience a systolic blood
pressure reduction of 28 points after 30 days.
Renal denervation is a specialized ablation procedure that has been
clinically proven to reduce blood pressure in patients with hypertension
that is resistant to medical therapy. A typical normal blood pressure is
below 120 systolic (the first number) and 80 diastolic (the second
number), and is expressed as 120/80 mmHg. Hypertension, or high blood
pressure, is a blood pressure greater than 140/90 mmHg.
Patients that enrolled in the trial had an average of 176 / 96 mmHg
baseline blood pressure despite being on multiple medications to help
control blood pressure. The results after 30 days demonstrated:
An average blood pressure of 148 / 87 mmHg, a 28 point reduction in
A reduction in systolic blood pressure to below 140 mmHg in 41 percent
"The risk of cardiovascular death doubles with every 20 point increase
in systolic blood pressure, so an average blood pressure reduction of 28
points is quite significant and demonstrates just how effective the
technology is," said the trial's Primary Investigator Prof. Stephen
Worthley, Royal Adelaide Hospital in Australia. "From other clinical
trials studying the impact of renal denervation we have learned that
blood pressure continues to be reduced over time, so I would not be
surprised to see this trend continue and see an even greater benefit for
Results from other clinical trials for competitive technologies studying
the safety and efficacy of renal denervation demonstrated that results
improve over time. After 30 days, a 14 point reduction in systolic blood
pressure was noted in a competitor's study, but this number improved to
a reduction of 27 points of systolic blood pressure after one year.
Compared to this competitive technology, the average 30-day results from
the EnligHTN renal denervation trial showed double the reduction in
blood pressure at 30 days. Further, the renal denervation treatment was
successfully delivered with no serious complications related to the
procedure or device.
Forty seven patients enrolled in the multicenter study. To be considered
for enrollment, patients were required to have a systolic blood pressure
above 160 (150 for patients with type 2 diabetes) and take at least
three antihypertensive medications concurrently at maximally tolerated
doses, including a diuretic.
"Hypertension accounts for millions of deaths every year, so it is
encouraging that just ahead of World Hypertension Day, new data
demonstrate that there is a safe and effective solution to help reduce
blood pressure in patients where other treatments aren't working," said
Frank J. Callaghan, president of the St. Jude Medical Cardiovascular
Division. "The EnligHTN system is truly a unique technology that we
believe has the potential to reduce a root cause of some of the world's
most burdensome cardiovascular diseases and help patients around the
world live more healthy lives."
Hypertension is a root cause of various life-threatening health
problems, including heart disease, stroke, and kidney failure. It
impacts more than 1 billion people globally, many of whom do not
respond to conventional treatment with medication.
About the EnligHTN Renal Denervation System
The EnligHTN system is a multi-electrode ablation technology for renal
denervation. With its unique basket design, each placement of the
ablation catheter administers a reliable and repeatable treatment
pattern. Compared to single-electrode ablations systems, the
multi-electrode EnligHTN system has the potential to improve
consistency, save time as well as result in workflow and cost
efficiencies. Additionally, minimal catheter repositioning may result in
a reduction of contrast and fluoroscopic (x-ray) exposure.
Using the new EnligHTN system, an ablation catheter delivers
radiofrequency (RF) energy to create lesions (tiny scars) along the
renal sympathetic nerves - a network of nerves that help control blood
pressure; the intentional disruption of the nerve supply has been
clinically found to cause systolic blood pressure to decrease.
The technology includes a guiding catheter, ablation catheter and
ablation generator. The generator uses a proprietary,
temperature-controlled algorithm to produce effective lesions.
St. Jude Medical recently received CE Mark approval for the EnligHTN
renal denervation system. Attendees of EuroPCR can see the EnligHTN
system on display at the St. Jude Medical booth or visit www.SJMenligHTN.com.
EuroPCR is the official congress of the European Association of
Percutaneous Cardiovascular Interventions (EAPCI), a leading
international course for interventional cardiovascular specialists.
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.
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 March 31, 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.
St. Jude Medical, Inc.
J.C. Weigelt, Investor Relations,
Bluestone, Media Relations, 651-236- 0837
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