The FDA has approved a device (geko, Sky Medical Technology) for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. A press release reports that this adds to Sky’s established 510k clearance for immediate post-surgical stimulation of calf muscles to prevent venous thromboembolism, increasing blood circulation and oedema reduction. It adds that this is the first muscle pump activator of its kind to be cleared by the FDA for venous thromboembolism prevention across all patients including non-surgical patients.
According to the press release, geko is a non-invasive, easy to use, battery powered, wearable therapy device. It is the size of a wristwatch and worn at the knee, the daily disposable device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf. The geko device operates without external pressure to the leg and allows complete mobility.
A study of the device to prevent venous thromboembolism in acute stroke patients reported 0% venous thromboembolism in patients wearing the device alone, compared to venous thromboembolism in the various control groups prescribed sequential compression devices at 2.4% or pharmacological prophylaxis at 1.1%. The investigators, led by Indira Natarajan (NHS Royal Stoke University Hospital, Stoke-on-Trent, UK), also determined that 30% of patients are contraindicated or became intolerant (discomfort or dislike) to sequential compress devices. It is to this unmet need cohort that the geko device was fitted, reporting a zero venous thromboembolism incidence and good patient tolerance. The data has driven rapid adoption across multiple NHS trusts and international markets, as well as the expanded FDA clearance.
Natarajan comments: “The data have shown a need to use the geko device when other venous thromboembolism prophylaxis strategies are contraindicated or impractical and provides an option where previously patients would have had no other intervention available to them. The geko device is now in routine use at the Royal Stoke and has marked significant change to our practice.”
Commenting on the FDA clearance, Sky CEO Bernard Ross says: “This latest 510(k) builds on our previous FDA indications to address life threatening blood clots and complications related to swelling after orthopaedic surgery, conditions experienced by more than 1 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, embedded in the geko device, completely redefines the way vascular related conditions are treated. Through our innovative mechanism of neuromuscular electrostimulation, we are the first clinically proven muscle activation technology to prevent and treat a wide range of acute and chronic circulatory conditions both here in the USA and internationally. New care pathways are in development in neurology, orthopaedics, renal, and peripheral vascular disease and we plan to submit further FDA applications to expand our claims.”
Sky Medical Technology is headquartered in the UK and backed by leading international investors in both healthcare and technology.