Reach Neuro’s Avantis Gets Breakthrough Nod for Chronic Stroke Impairments

The FDA has granted Breakthrough Device designation to Reach Neuro’s Avantis platform to help restore shoulder, arm and hand movement for patients with chronic stroke-related impairment.

Avantis delivers electrical impulses to the spinal cord to restore a patient's ability to control movement, enabling the patient to benefit from physical or occupational therapy.

The technology is currently being tested in a clinical trial at University of Pittsburgh Medical Center where the first two study participants showed 40 percent and 108 percent improvements in grip strength, respectively, and up to 124 percent improvement in joint strength.

The FDA gives priority review to applications for products granted Breakthrough Device status, a designation for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions.

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