FDA Approves New Device to Prevent Venous Thromboembolism

The US Food and Drug Administration (FDA) has cleared the way for the geko device for stimulation of calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE).

Sky Medical Technology, a UK-based medical device company, received 510k clearance for the device that increases blood circulation and edema reduction in this patient population. The device represents the first muscle pump activator to receive FDA clearance for VTE prevention across all patients, including non-surgical patients.

The daily disposable device is non-invasive, battery powered, wearable, about the size of a wristwatch, and worn at the knee. It works by gently stimulating the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf without external pressure to the leg, allowing complete mobility.

In testing, 0% of acute stroke patients reported VTE wearing the geko device alone, while 2.4% of patients various control groups using compression devices and 1.1% of patients prescribed a pharmacological prophylaxis reported VTE.

The investigators also determined that 30% of patients are contraindicated or become intolerant to a sequential compression device (SCD).

“The data has shown a need to use the geko device when other VTE prophylaxis strategies are contraindicated or impractical and provides an option where previously patients would have had no other intervention available to them,” Indira Natarajan, MD, consultant stroke physician and clinical director for neurosciences at the NHS Royal Stoke University Hospital, said in a statement. “The geko device is now in routine use at the Royal Stoke and has marked significant change to our practice.”

Hospitalized patients are at an increased risk for VTE, especially immobile patients. According to the US Centers for Disease Control, fewer than 50% of hospital patients receive appropriate preventative treatment for VTE and between 60,000-100,000 die in the US annually as a result of the condition, 10-30% of which die within 1 month of diagnosis.