Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism.
The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients.
Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko 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.
A study of the geko, consultant stroke physician and clinical director for neurosciences at the NHS Royal Stoke University Hospital, also determined that 30% of patients are contraindicated or became intolerant to SCDs (discomfort or dislike to SCDs). It is to this unmet need cohort that the geko
Commenting on FDA’s clearance, Sky CEOsaid, "This latest 510(k) builds on our previous FDA indications to address life-threatening blood clots and complications related to swelling after orthopedic surgery, conditions experienced by more than one million US patients with unmet need every year. We are excited to extend our access into the US market. Our muscle pump activation technology, OnPulse