A Medical Device Daily

St. Jude Medical (SJM; St. Paul, Minnesota) reported receipt of CE-mark approval of its Genesis neurostimulation system for managing chronic angina pectoris, or chronic angina.

About the size of a stopwatch, 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.

"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 St. Jude Medical's 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. About54 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 J.L. DeJongste, MD, of the Thoraxcenter at University Medical Center 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."

Clas Mannheimer, MD, of the Multidisciplinary Pain Center at Östra Hospital (Gothenburg, Sweden), said, "People living with chronic angina often face a poor quality of life due to constant or recurring physical pain and loss of social function. Neurostimulation provides a minimally invasive treatment option for managing this painful condition."

SJM said 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.

CE mark for laser/light products

MedX Health (Mississauga, Ontario), a developer of drug free, non-invasive, low level laser and light therapy for tissue repair and pain relief, said it has received CE-mark approval to market and sell its family of MedX laser and light products in all 25 European Union (EU) and three European Free Trade Association (EFTA) member states.

"CE-mark approval allows MedX to establish its global presence beyond North America, and further validates the benefits delivered through our non-invasive, drug-free products," said President/CEO Steve Guillen. "This announcement comes shortly after achieving the International Organization of Standardization [ISO] re-certification, demonstrating to outside regulatory bodies that the highest quality standards are in place at MedX."

MedX is focused on bringing symptom relief in a non-pharmacologic manner to the rehabilitation/chiropractic/sports medicine markets.

The company said that through a growing international distributor network, which now includes the European Union, it intends to expand its global reach and increase its revenue stream.

It said strong patent protection as well as developing and commercializing advanced products in the dental and wound care markets also will help position the company to increase revenues around the world.

HELIOS to add Varian products

The HELIOS Kliniken Group (Berlin) said it is acquiring nine linear accelerators from Varian Medical Systems (Palo Alto, California), the majority of them equipped with RapidArc technology for fast and comfortable radiotherapy treatments.

HELIOS, one of the three largest private clinic groups in Germany, offers radiotherapy at six hospitals in Krefeld, Wuppertal, Schwerin, Bad Saarow, Berlin-Zehlendorf and Berlin-Buch.

The new machines will be installed at each of these sites, replacing older models and adding capacity that the HELIOS group said will give more patients access to the most advanced cancer care. Each site also will receive a suite of Varian's ARIA oncology information management software and Eclipse treatment planning software. Three of the hospitals also will receive a new GammaMed brachytherapy afterloader.

The new equipment will be installed in stages over the next two years. HELIOS, a business unit of the global health care company Fresenius, owns 62 hospitals across Germany. In 2008, 63,000 cancer patients were treated in HELIOS hospitals.

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