Sky Medical Technology Ltd (Sky) has today announced it has achieved further U.S. 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 ischemia.
This latest (W3) geko™ device 510(k) follows the company’s prior 2021 FDA clearance for the (W2) geko™ device, also authorized for venous insufficiency and/or ischemia. The new (W3) geko™ device clearance brings with it the added benefit of a 3rd electrode, enabling greater patient reach (nerve stimulation), patient comfort and better patient outcomes – and an increase to two 12 hour therapeutic doses, where previously the (W2) device provided two 6 hour doses.
Venous insufficiency and ischemia 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 ischemia are left untreated, progression of CVI can lead to post-phlebitic syndrome and venous leg ulcers.[i]
Three recently published studies, by Das[i],[ii] and Bosanquet[iv] demonstrate the geko™ device generates microcirculatory blood flow increase in the lower limbs of patients with venous insufficiency and ischemia. Both studies measured the increase using Laser Speckle Contrast Imaging, a non-invasive technique that measures blood flow.
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 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 ischemia 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[v], at a rate equal to 60 percent of walking without a patient having to move.[vi] The device operates without external pressure to the leg and allows complete mobility.
Sky is headquartered in the UK and backed by leading international investors in both healthcare and technology.
[i] Patel SK et al. Venous Insufficiency. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan. 2021 Aug 4.
[ii] Das et al. Neuromuscular stimulation of the common peroneal nerve increases arterial and venous velocity in patients with venous leg ulcers. Int Wound J. 2020;1–7. DOI: 10.1111/iwj.13510. September 2020.
[iii] Das et al. Microcirculatory changes in venous leg ulcers using intermittent electrostimulation of common peroneal nerve, Journal of Wound Care. Vol 30, No 2. February 2021.
[iv] Bosanquet DC et al. Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve. Published by Elsevier Inc. Open access article under the CC BY-NC-ND license. Manuscript received: May 14, 2020; manuscript accepted: July 9, 2020; published online.
[v] Nicolaides A, Griffin M. Measurement of blood flow in the deep veins of the lower limb using the geko™ neuromuscular electro-stimulation device. Journal of International Angiology August 2016-04.
[vi] Tucker A et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. The International journal of angiology: official publication of the International College of Angiology, Inc. 2010 Spring;19(1): e31-7.