|[February 15, 2013]
St. Jude Medical Initiates Landmark Study of Renal Denervation for Reduction of Heart Attack, Stroke and Death
ST. PAUL, Minn. --(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced plans for a new landmark study that will evaluate
whether renal denervation and medication can provide health benefits to
patients beyond lowering high blood pressure. The EnligHTNment trial is
the first large-scale study that will examine the long-term effects of
renal denervation in patients who have uncontrolled hypertension to see
if renal denervation also reduces the risk of major cardiovascular
events such as heart attack, stroke and death.
Image of the St. Jude Medical EnligHTN(TM) Renal Denervation System. (Courtesy St. Jude Medical)
Uncontrolled hypertension occurs when blood pressure in the arteries
remains elevated, requiring the heart to work harder than normal to
circulate blood throughout the body. This condition puts one in three
adults worldwide at risk of heart attack, stroke and kidney failure
according to the World
Health Organization (WHO). Additionally, the WHO estimates that 7.5
million deaths each year, or 13 percent of all deaths can be
attributed to raised blood pressure. This includes 51 percent of deaths
due to stroke and 45 percent of deaths due to coronary heart disease.
"To date, the renal denervation studies that have been conducted only
looked at reducing blood pressure in patients with uncontrolled or
resistant hypertension," said Professor Michael Böhm, director and chief
of internal medicine and cardiology at the University of Saarland in
Homburg/Saar, Germany, a principal investigator for the trial. "What we
need to know is if this minimally invasive approach for treating
hypertension also correlates to a reduction in major cardiac events such
as heart attack, stroke and death, which are the primary risks for
patients whose blood pressure is not well controlled."
Renal denervation therapy is a minimally invasive procedure that uses
radiofrequency (RF) energy to disrupt the renal nerves, which lead in
and out of the kidneys. The RF energy creates 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.
"Initial study results have demonstrated that the EnligHTN Renal
enervation System is safe and effective in rapidly lowering blood
pressure. If these results extend into the prevention of major cardiac
events, there is the potential to dramatically change how we treat these
patients," said Professor Thomas Lüscher, chairman, cardiology and
cardiovascular center at the University Hospital in Zurich, Switzerland,
a principal investigator for the trial.
The EnligHTNment trial will be an international, multi-center,
randomized, controlled study examining the safety and effectiveness of
renal denervation with the EnligHTN™ Renal Denervation System in
reducing risk of major cardiovascular events.
"We are committed to making the right investments to lead the emerging
field of interventional treatment for hypertension," said Frank J.
Callaghan, president of the St. Jude Medical Cardiovascular and Ablation
Technologies Division. "Like other landmark trials we have sponsored,
this first-of-its kind study provides the opportunity to evaluate
patient outcomes that matter the most - heart attack, stroke and death."
St. Jude Medical is currently conducting two additional renal
denervation studies called EnligHTN I and EnligHTN II that are
evaluating the EnligHTN system for hypertension. Results to-date from
I trial 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 rapidly reduced by an average of 28 mmHg that remained
stable with a reduction of 26 mmHg points six months after treatment.
This is an important finding as the risk of cardiovascular death drops
by half with every systolic decrease of 20 mmHg. The EnligHTN II trial
is being conducted at 40 sites in Europe and Australia and will enroll
approximately 500 patients with uncontrolled hypertension. The study
began enrollment in January 2013 to evaluate the reduction in systolic
blood pressure at six months across all enrolled patients after having
renal denervation, and within sub-groups with varying degrees of kidney
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 hypertension. A catheter is introduced through the femoral artery
in the leg to access the renal arteries that connect to the kidneys.
Once in place, the tip of the catheter is held against the surface of
the artery where radiofrequency (RF) energy is delivered to the
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
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 sjm.com.
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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 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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