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geko™ device

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The geko™ device receives FDA 510(k) clearance to market in the USA for prevention of venous thrombosis (DVT)

28/06/2018

Firstkind Ltd, a subsidiary of Sky Medical Technology Ltd, announces FDA clearance for USA commercialization of their geko™ neuromuscular stimulator, indicated for increased local blood circulation, and for immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The size of a wrist-watch and worn at the knee, the battery powered geko™ device delivers gentle electrical impulses to the common peroneal nerve, activating the muscle pumps of the lower leg to increase venous, arterial and microcirculatory blood flow. The mechanism of action emulates the blood flow rate normally achieved by walking – up to 60% – without the patient having to move or exert energy. Self-adhesive, the geko™ device, encased in a flexible moulded strap, fits comfortably to the leg, just behind the knee.

“This achievement is testament to the ongoing dedication of our team to deliver value through better patient outcomes.” says Bernard Ross, CEO. “With this approval, we now look forward to building a strong surgical network across the USA to address areas of immediate unmet need in thromboembolism prophylaxis in all postsurgical patient groups.”

This FDA marketing authorisation follows the recent UK National Institute of Care Excellence (NICE)
guidance issued in June 2014 recommending the use of the geko™ device for VTE prevention across all patients groups throughout the National Health Service.