The FDA has given the go-ahead to the geko device, a wearable that uses electricity to stimulate leg muscles. By increasing circulation through stimulation of a central nerve near the shin, the geko can ward off issues like blood pooling and varicose veins, both symptoms of chronically blocked blood vessels.
U.K.-based Sky Medical developed this disposable, wristwatch-sized device to be worn around the lower part of the knee. It transmits pumping signals to foot and calf muscles, increasing artery and vein blood flow in the lower limbs while avoiding the drawbacks of similar devices, such as additional external pressure or reduced mobility during operation.
The FDA's 510(k) clearance gives Sky Medical the opportunity to embark on a controlled market release of the geko for first-line treatment of ischemia and venous insufficiency. In hopes of augmenting its claims about venous insufficiency as well as overall blood flow, Sky plans to submit further 510(k) applications to the agency. The company's research estimates that, annually, around 150,000 people receive a chronic venous insufficiency diagnosis. Left untreated, the condition can cause debilitating leg ulcers and myriad other complications.
