FDA approves stroke rehabilitation therapy created at UT Dallas

How many time does this exact same research need to be published before your hospital does ONE DAMN THING with it? 

• Vivistim® System (3 posts to February 2015)

• Vivistim™ (1 post to June 2018)

The latest here:

FDA approves stroke rehabilitation therapy created at UT Dallas

The FDA approval is being called ‘the most significant success’ in the Biomedical Device Center’s nine-year history.

A stroke rehabilitation system created at the University of Texas at Dallas recently received approval from the Food and Drug Administration.(Ben Torres / Special Contributor)

By Cecilia Lenzen

9:55 AM on Sep 15, 2021 CDT — Updated at 9:53 AM on Sep 16, 2021 CDT

Updated at 9:53 a.m. Thursday to clarify what received FDA approval.

A stroke rehabilitation method invented at the University of Texas at Dallas recently received approval from the Food and Drug Administration.

The system that treats chronic ischemic stroke survivors is the first of its kind, according to a UT Dallas press release.

Most strokes (87%) are ischemic strokes, which are often caused by blood clots, according to the Centers for Disease Control and Prevention. An ischemic stroke happens when blood flow through the artery that supplies oxygen-filled blood to the brain becomes blocked.

The Vivistim Paired VNS System was produced and commercialized by MicroTransponder, a company started by UT Dallas graduates, according to the release. Patients with arm and hand weakness after a stroke were studied while pairing the rehabilitation system with rehabilitation exercises. The study showed that those patients improved two to three times more than the control group patients, who received rehab alone, the release said.

Every year, more than 795,000 people in the U.S. experience a stroke, according to the CDC. Increasing the effectiveness of physical rehabilitation for mobility and motor skills could help improve quality of life for many stroke victims, according to the release.

Dr. Michael Kilgard, interim executive director of the Biomedical Device Center, said in the release that the FDA’s approval of this rehabilitation system is “the most significant success” in the center’s nine-year history.

“This announcement means that stroke survivors all over the country can soon begin receiving a safe and effective therapy to improve their recovery,” Kilgard said in the release.

For more information on the rehabilitation system, click here.

CORRECTION, 9:53 a.m., Sept. 16, 2021: An earlier version of this story and the headline indicated that the center received FDA approval, rather than the rehabilitation system.