UK-based medical devices maker Sky Medical Technology has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its geko device to stimulate calf muscles for the prevention of venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE).

The geko is a non-invasive, battery powered and wearable therapy device, which will be placed at the knee to stimulate the common peroneal nerve for the activation of calf and foot muscle pumps.

Sky Medical’s geko device operates without external pressure to the leg

Sky Medical’s daily disposable device will help increase blood flow in the deep veins of the calf. The geko device, which operates without external pressure to the leg, enables complete mobility.

According to the company, the study to prevent VTE in acute stroke patients showed that 0% VTEs in patients wearing a geko device alone compared to VTEs in the various control groups prescribed sequential compression devices at 2.4% or pharmacological prophylaxis at 1.1%.

Sky Medical Technology CEO Bernard Ross said: “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.”

Sky Medical Technology, the parent of Firstkind, has developed OnPulse NMES technology platform that was integrated into geko device.

The company develops a range of products for different clinical applications, including DVT prevention, the treatment and reduction of edema and wound healing.

In March 2018, Sky Medical Technology secured 510(k) clearance from the FDA or its geko medical device to treat pre- and post-operative oedema (swelling).