DARESBURY, England, Dec. 16, 2021 / PRNewswire / – Medical device company Sky Medical Technology Ltd today announced the U.S. Food and Drug Administration (FDA) 510 (k) clearance to market the geko â¢ device to increase microcirculatory blood flow in the soft tissues of the lower limbs of patients with venous insufficiency and / or ischemia.
The geko â¢ device is the first electrical neuromuscular stimulator of its kind to be licensed to increase microcirculatory blood flow and adds to Sky’s previous FDA clearances for edema reduction and calf muscle stimulation to prevent venous thrombosis (blood clots) in surgery and non-surgical patients.
Venous insufficiency and ischemia are linked to decreased blood flow in the veins and arteries. This can lead to edema of the lower extremities, skin changes and discomfort. Venous insufficiency can progress to chronic venous insufficiency (CVI), a serious disease attributed to a decrease in quality of life and loss of productivity at work. 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 to care for these patients. If venous insufficiency and ischemia are not treated, progression to CVI can lead to post-phlebitic syndrome and venous leg ulcers1.
Three recently published studies, two led by Das2,3, the other led by Bosanquet4 demonstrate that the geko â¢ device generated an increase in microcirculatory blood flow in the lower limbs of patients with venous insufficiency and ischemia. Both studies measured the increase using laser spot contrast imaging, a non-invasive technique that measures blood flow.
CEO and Founder Bernard Ross said: âObtaining this latest 510 (k) authorization is an important step for Sky which will allow us to launch a controlled commercialization of the geko â¢ device, to treat venous insufficiency and ischemia. in the first place – a Therapeutic field is in dire need of innovation. With this 510 (k) and in partnership with leading US clinicians, we can now move forward to redefine how vascular conditions can be treated.
The geko â¢ device is a portable, non-invasive, easy-to-use therapy device. The size of a wristwatch and worn over the knee, the disposable device gently stimulates the common peroneal nerve by activating muscle pumps in the calf and foot, resulting in increased blood flow to the deep veins in the calf. a rate equal to 60% 6 to walk without a patient having to move. The device works without external pressure on the leg and allows full mobility.
The company is headquartered in the UK and is backed by leading international healthcare and technology investors. The company is in the process of making further 510 (k) requests to the FDA to expand its claims related to increased blood flow to remedy venous insufficiency.
1. Patel SK et al. Venous insufficiency. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan 2021 4 Aug.
2. Das et al. Neuromuscular stimulation of the common peroneal nerve increases arterial and venous speed in patients with venous leg ulcers. Int Wound J. 2020; 1-7. DOI: 10.1111 / iwj.13510. September 2020.
3. Das et al. Microcirculatory Changes in Venous Leg Ulcers Using Intermittent Common Fibular Nerve Electrical Stimulation, Journal of Wound Care. Vol 30, No 2. February 2021
4. Bosanquet DC et al. Microcirculatory flow 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 CC BY-NC-ND license. Manuscript received: May 14, 2020; manuscript accepted: July 9, 2020; published online.
5. Nicolaides A, Griffin M. Measurement of blood flow in the deep veins of the lower limb using the geko â¢ neuromuscular electrostimulation machine. Journal of International Angiology August 2016-04.
6. Tucker A et al. Increased venous, arterial and microvascular blood supply to 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 electrostimulation mechanism, Sky has developed a revolutionary NMES technology platform, OnPulse â¢, integrated with its industry-leading product, the geko â¢ device. The company develops a range of products tailored to the needs of different areas of medical applications, 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 path is to partner with healthcare professionals to improve clinical outcomes and patient care while conserving healthcare system resources.
Sue Davenport, +44 7771 667 170, [email protected]
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SOURCE Sky Medical Technology Ltd.