St. Jude Medical, Inc. today announced European CE Mark approval of 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 percent 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 J.L. DeJongste, M.D., 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 percent fewer episodes of angina and lowered their nitrate use by 89 percent 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 U.S. for the treatment of chronic angina.
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