Sky Medical Technology has announced it has achieved further US Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischaemia, according to a press release.
This latest (W3) geko device 510(k) follows the company’s prior 2021 FDA clearance for the (W2) geko device, also authorised for venous insufficiency and/or ischaemia. The new (W3) geko device clearance brings with it the added benefit of a 3rd electrode, enabling greater patient reach (nerve stimulation), patient comfort, better patient outcomes, and—an increase to two 12 hour therapeutic doses, whereas previously the (W2) device provided two six-hour doses.
Venous insufficiency and ischaemia relate to reduced blood flow in the veins and arteries. This can lead to lower extremity oedema, skin changes, and discomfort. Venous insufficiency can progress to chronic venous insufficiency (CVI), a serious condition attributed to diminished quality of life and loss of work productivity. In most cases, the cause is incompetent valves. Each year approximately 150,000 new patients are diagnosed with chronic venous insufficiency, and nearly $500 million is used in the care of these patients. If venous insufficiency and ischaemia are left untreated, progression of CVI can lead to post-phlebitic syndrome and venous leg ulcers.
The geko device (W3) 510(k) adds to Sky’s portfolio of FDA clearances, which include oedema reduction and stimulation of the calf muscles to prevent venous thrombosis (blood clots) in both surgical and non-surgical patients.
CEO and Founder, Bernard Ross (Liverpool, UK) commented, “Achieving this latest 510(k) clearance for the geko device (W3) establishes Sky’s position as a leading innovator in MedTech dedicated to improving patient outcomes. Conditions such as venous insufficiency and ischaemia are therapy areas sorely in need of innovation, and we are pleased to contribute to improvements in this care pathway that make recovery quicker, simpler, and more comfortable.”
The geko device is a non-invasive, easy-to-use, wearable therapy device. The size of a wristwatch and worn at the knee, the 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, at a rate equal to 60 percent of walking without a patient having to move, according to the press release.
The device operates without external pressure on the leg and allows complete mobility.