St Jude Medical receives EU approval for neurostimulation system for
chronic angina
12 March 2009
St Jude Medical, Inc. (NYSE:STJ) has announced that it has received
European CE Mark approval for its Genesis neurostimulation system for
managing a form of chest pain known as chronic angina pectoris, or
chronic angina.
Approximately the size of a stopwatch, this neurostimulation system
helps to control angina pain by sending mild pulses of electricity from
a device implanted in the torso via thin insulated wires called leads to
nerves located along the spinal cord.
“This approval is an important step forward in being able to provide
pain solutions for people who have exhausted most other treatments,”
said Chris Chavez, president of the St. Jude Medical Neuromodulation
Division. “Our goal is to continue to develop new applications for our
medical technologies and to provide physicians with more options in
their choice of treatments.”
Angina is chest pain or discomfort that usually occurs as a result of
decreased blood and oxygen supply to the heart, and it is the most
prevalent symptom of coronary heart disease. It is often described as a
squeezing pain in the chest, shoulders, arms, neck, jaw or back and is
sometimes described as feeling like indigestion. Approximately 54
million people worldwide have angina according to the World Health
Organization. An estimated 15% of all angina cases are considered
chronic, equating to approximately 8.1 million people worldwide who live
with chronic angina.
“While the stimulator will help mask the pain of angina, studies have
shown that neurostimulation will not mask the pain of a heart attack,”
said Mike JL DeJongste, MD, department of cardiology, Thoraxcenter,
University Medical Center, University of Groningen, Groningen, The
Netherlands. “This therapy is designed to provide relief for those
patients who suffer from chronic angina that does not respond
sufficiently to optimal medication and revascularization treatments.”
Chronic angina persists despite medications such as nitroglycerin,
beta blockers or calcium channel blockers, which are often used to treat
coronary artery disease. For some of these patients, revascularization
procedures such as coronary angioplasty or bypass surgery (which are
intended to restore blood flow to the heart) may pose too much risk.
A study published in the journal Heart found that
neurostimulation was effective at reducing angina and the need for
nitrate medications to treat it. In the study, angina patients who used
neurostimulation several times a day had 86% fewer episodes of angina
and lowered their nitrate use by 89% compared to periods in which they
received placebo treatment.
“People living with chronic angina often face a poor quality of life
due to constant or recurring physical pain and loss of social function,”
said Clas Mannheimer, professor, Multidisciplinary Pain Center, Östra
Hospital, Gothenburg, Sweden. “Neurostimulation provides a minimally
invasive treatment option for managing this painful condition.”
In addition to chronic angina, the Genesis neurostimulation system is
approved for treating chronic neuropathic pain of the trunk and limbs
and pain from back surgeries that have failed. More than 45,000 patients
in 35 countries have been implanted with St. Jude Medical
neurostimulation systems. Patients can obtain more information about
neurostimulation pain therapies at www.PowerOverYourPain.com.
The Genesis neurostimulation system has not been approved in the US
for the treatment of chronic angina.
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