St. Jude Medical's Neurostimulation System Receives CE Approval for Chronic Angina

 

March 11, 2009

March 11, 2009 - The St. Jude Medical Genesis neurostimulation system designed for managing chronic angina pectoris, or chronic angina, has received European CE approval.

The Genesis 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.

“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 who 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.”

The Genesis neurostimulation system has not been approved in the U.S. for the treatment of chronic angina.

For more information: www.sjm.com

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