UK-based Sky Medical Technology has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its geko medical device to treat pre- and post-operative oedema (swelling).
The patented neuromuscular electrostimulation technology is said to be used to improve patient care in the lead up to and after orthopaedic surgery.
The latest clearance is additional to the earlier FDA approval for the use of geko in venous thromboembolism (VTE) prevention.
Featuring the firm’s OnPulse neuromuscular electro-stimulation technology, the geko is a battery-powered, self-adhesive and disposable device, which is similar to the size of a wristwatch and worn at the back of knee.
By generating gentle electrical impulses, the device will stimulate the common peroneal nerve to activate the calf and foot muscle pumps, helping to increase blood flow and reduce oedema.
According to the company, the increase in blood flow is equal to 60% of walking, without a patient having to move or exert any energy.
Sky Medical Technology CEO Bernard Ross said: “The American healthcare market is receptive to any new innovation that can provide high-impact therapies that address unmet clinical needs, and this latest clearance reflects our strengths in this very arena.
“Our cutting-edge products and evidence-based therapies – developed in the UK and then exported globally – are helping to establish new standards of care that simplify treatments for clinicians and improve patient outcomes.
“The growth of our export business has been a direct result of our collaboration with early adopters in the UK to generate proven clinical and health economic data that can translate globally.”
Sky Medical provides solutions to be used for the reduction of of oedema, prevention of VTE, wound healing and elite sport recovery. The firm develops a range of products to be used in different medical application areas.
Image: Sky Medical Technology CEO Bernard Ross. Photo: courtesy of Sky Medical Technology.