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NeuroControl StIM(TM) System Receives Approval from the Food and Drug Administration to Begin Clinical Trial.

Minimally invasive stimulator studied to treat

shoulder pain associated with stroke

CLEVELAND, Aug. 1 /PRNewswire/ --

NeuroControl Corporation received Investigational Device Exemption (IDE) Approval from the Food and Drug Administration (FDA) today to begin a multi-center clinical study using the StIM(TM) System, the world's first miniaturized multi-channel programmable neuromuscular stimulator. The study is being conducted to gather data to support a FDA submission for the treatment of shoulder pain after stroke. To date, 23 patients have been treated with this device with encouraging clinical results.

StIM is a breakthrough neuromuscular stimulator for people who have had a stroke. The minimally invasive therapeutic device is intended to reduce shoulder pain and subluxation (shoulder subluxation is the separation of the shoulder joint due to weak muscles) and improve upper extremity function after stroke.

"Stroke is the third leading cause of death in the United States and the leading cause of serious long term disability," said Donna Richardson, president and chief executive officer of NeuroControl Corporation, the company that developed the device. "There are 750,000 cases of stroke in the United States annually and approximately 150,000 people could potentially benefit from the StIM System for pain after stroke," said Donna Richardson, president and chief operating officer of NeuroControl Corporation, the company that developed the device.

Richardson added that the StIM System received CE Mark Approval in January to market the device in Europe.

How it works

StIM consists of a microprocessor-based, eight-channel stimulator that is as small as a pager, lightweight, portable and battery-powered. Therapeutic stimulation is delivered through electrodes, placed in the shoulder muscles using a minimally invasive technique.

The easy-to-use NeuroControl StIM System directs electrical pulses, which cause the muscles of the shoulder to contract in controlled patterns, reducing shoulder subluxation and pain. The treatment is usually applied for a period of six weeks, and electrodes are easily removed at the end of treatment.

Who it helps

People who have had a stroke and may benefit from the device include those who also have:

* shoulder pain,

* shoulder subluxation, and

* paralysis of one side of the body (hemiplegia).

Participating Centers

* Clinical sites participating in the multi-center study include:

* Rehabilitation Institute of Chicago

* Mount Sinai Medical Center (NY)

* Cleveland Clinic Foundation

* University of Pennsylvania Health System

* Barnes-Jewish Hospital (St. Louis)

* Charlotte Institute of Rehabilitation

* James A. Haley Veterans Hospital (Tampa)

* MetroHealth Medical Center

About NeuroControl Corporation

Headquartered in Cleveland, NeuroControl Corporation markets products that restore function to persons with paralysis. Products include the FREEHAND(R) System, an implant that restores hand function to people with quadriplegia. The FREEHAND System received FDA Premarket (PMA) Approval in 1997 and more than 160 people have received the device worldwide. The VOCARE(TM) Bladder System restores bladder and bowel function in men and women with complete spinal cord injury. The VOCARE Bladder System received FDA Approval under the Humanitarian Device Exemption (HDE) provision in early 1999 and more than 1,600 people have received the implant worldwide. NeuroControl Corporation recently became the worldwide distributor of the NeuroControl Seager System, a non-surgical device that treats male infertility. NeuroControl Corporation was founded in 1993. For more information, contact NeuroControl Corporation toll free, 888-333-4918, or by web site, www.neurocontrol.com .
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Date:Aug 1, 2000
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