Sky Medical Technology Obtains New FDA Clearance to Market New Device Variant (W3) geko™ for Venous Insufficiency and Ischemia

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This latest (W3) geko™ 510(k) device follows the company’s 2021 FDA preclearance for the (W2) geko™ device, also cleared for venous insufficiency and/or ischemia. The new device release (W3) geko ™ brings with it the added advantage of a 3rd electrode, allowing for greater patient reach (nerve stimulation), patient comfort, and better patient outcomes – and an increase to two 12-hour therapeutic doses, where previously the device (W2) provided two 6-dose time.

Venous insufficiency and ischemia are linked to decreased blood flow in veins and arteries. This can lead to lower extremity edema, skin changes and discomfort. Venous insufficiency can progress to chronic venous insufficiency (CVI), a serious condition attributed to decreased 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 almost $500 million is used in the management of these patients. If venous insufficiency and ischemia are not treated, progression of CVI can lead to postphlebitic syndrome and venous leg ulcers.[i]

Three recently published studies, by Das[ii],[iii] and Bosanquet[iv] demonstrate that the geko™ device generates an increase in microcirculatory blood flow in the lower limbs of patients suffering from venous insufficiency and ischemia. Both studies measured the increase using laser speckle contrast imaging, a noninvasive technique that measures blood flow.

geko™ (W3) 510(k) device adds to Sky’s portfolio of FDA clearances, which includes reducing edema and stimulating calf muscles to prevent venous thrombosis (blood clots) in patients surgical and non-surgical.

CEO and Founder, Bernard Ross commented: “Receiving this latest 510(k) clearance for the geko™ (W3) device establishes Sky’s position as a leading innovator in medical technologies dedicated to improving patient outcomes. patients. Conditions such as venous insufficiency and ischemia are therapeutic areas in dire need of innovation, and we are happy to help improve this care pathway that makes recovery faster, easier and more comfortable.”

The geko™ device is a portable, non-invasive, easy-to-use therapy device. Wristwatch-sized and worn on the knee, the disposable device gently stimulates the common peroneal nerve activating muscle pumps in the calf and foot, resulting in increased blood flow to the deep veins of the calf[v]at a rate equal to 60% of walking without a patient having to move.[vi] The device works without external pressure on the leg and allows complete mobility.

Sky is headquartered in the UK and is backed by leading international healthcare and technology investors.

REFERENCES

[i] Patel SK et al. Venous insufficiency. In: StatPearls [Internet]. treasure island (FL): StatPearls Publishing; 2021 Jan 2021 August 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 electrical stimulation of the common peroneal nerve, Journal of Wound Care. Vol 30, No 2. February 2021

[iv] Bosanquet DC et al. Microcirculatory flow and pulsatility in arterial leg ulcers are increased by intermittent neuromuscular electrical stimulation of the common peroneal nerve. Published by Elsevier Inc. Open access article licensed under CC BY-NC-ND. 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 electrostimulation device. Journal of International Angiology August 2016-04.

[vi] Tucker A et al. Increase in venous, arterial and microvascular vascularization of 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.

About Sky Medical Technology Ltd and Firstkind Ltd

Sky Medical Technology, the parent company of Firstkind Ltd, is a UK-based medical device company. Using its innovative non-invasive neuromuscular electrical stimulation mechanism, Sky has developed a breakthrough NMES technology platform, OnPulse™, integrated into its industry-leading product, the geko™ device. The company develops a range of products tailored to the needs of different areas of medical application, selling both directly and through strategic partnerships or distributors in each major clinical area. Clinical areas of interest include prevention of DVT, treatment and reduction of edema and venous insufficiency. The goal of each pathway is to partner with healthcare professionals to improve clinical outcomes and patient care while saving healthcare system resources.

Media contact

Emilie Lauri
[email protected]
+44(0)7815 578 511

SOURCESky Medical Technology


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