Ekso Bionics Holdings Inc.’s Ekso GT is the first robotic exoskeleton cleared by FDA for use by stroke patients with spinal-cord injuries or hemiplegia, the company said.

The agency cleared the system on April 4 for individuals with spinal-cord injuries at levels T4 to L5, and at levels L3 to C7 (ASIA D). It is intended to enable patients to stand up and walk, bearing their full weight.

The system is cleared for use only in rehabilitation institutions. Meanwhile, the main competing system from the firm ReWalk Robotics is also cleared for use outside of the clinic. (See [A#01140630014].)

Video: Ekso GT

Ekso Bionics Holdings Inc.

“Our strategy has been to concentrate on the rehabilitation clinic, with a focus on ease of use, rapid turnover between sessions, and efficacy for a range of patients,” said Thomas Looby, president and interim CEO at Ekso Bionics. “Clinics using the Ekso GT are able to offer exoskeleton therapy to the widest patient population among all exoskeletons on the market, which we believe will translate into broader adoption of exoskeletons by hospitals and rehabilitation clinics."

Ekso previously sold its system as a class I, 510(k)-exempt device, but it submitted a 510(k) in late 2014 following FDA's designation of the category as class II. (See [A#01141208009].)

The system includes the "smart" Variable Assist software. It is designed for use at rehabilitation institutions, providing adaptive amounts of power to either side of the patient’s body.

The technology can help mobilize patients early in their recovery and throughout the continuum of care with a significant number of high intensity steps, Ekso says.

Annually, an estimated 375,000 suffer a spinal-cord injury globally, and an estimated 17 million suffer a stroke. More than 60% of acute stroke survivors are unable to walk or need intervention with walking.

The Ekso GT exoskeleton is also marketed as the SmartAssist outside of the US.

Ekso GT Robotic Exoskeleton Cleared For Stroke Indication

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