Sky Medical Technology, Daresbury
Sky Medical Technology is a UK-based medical device company that has developed an innovative neuromuscular electrostimulation technology to increase blood circulation to address a range of circulatory disorders. The company’s award winning geko™ device is the first bioelectronic device of its kind to receive both NICE guidance and FDA clearance.
The battery-powered geko™ device, which is the size of a wristwatch and worn at the knee, gently stimulates the common peroneal nerve with painless electrical pulses, activating the calf and foot muscle pumps, returning blood from the lower leg to the heart at a rate equal to 60 percent of walking, without a patient having to move. The device addresses multiple clinical application areas, most notably the prevention of life threatening venous thromboembolism (VTE), a condition where blood clots form in the deep veins of the leg (known as deep vein thrombosis or DVT) and travel in the circulation, lodging in the lungs (known as pulmonary embolism or PE). The device is also used to manage complications related to post-operative and trauma based oedema and the prevention and treatment of hard-to-heal wounds (leg ulcers).
In the focus application of blood clot prevention, there are more than 100,000 strokes in the UK every year – a number set to rise by almost 44% in the next 20 years. Action on stroke is an acknowledged priority, as part of NHS England’s Long-Term Plan announced in May 2019.
VTE prevention methods include blood thinning drugs and/or intermittent pneumatic compression (IPC) to increase blood flow. However, some patients cannot tolerate compression (i.e. due to fragile skin). The VTE risk associated with an immobile acute stroke patient is significant and the need for an alternative to IPC is real. The baseline VTE incident risk reported in the CLOTS3 study control arm (no IPC, plus standard measures) is 8.7%
Dr Indira Natarajan, a consultant stroke physician and Clinical Director of Neurosciences at the Royal Stoke University Hospital, conducted an observational pilot study to determine how effective the geko™ device is in preventing VTE. The geko™ device was fitted to patients unable to tolerate IPC.
The 1,000 patient real-world data shows that, of the 463 patients treated with IPC, as the standard of care, 11 patients (or 2.4%) suffered a VTE event. Of the 203 patients treated with the geko™ device there was no incidence of VTE reported. The study measured VTE events at 90 days post-stroke.
Proof that this unmet need is real and meaningful, can be demonstrated by the seven acute stroke units across England that have fully embedded the geko™ device as part of a pathway transformation within the past 12 months. The data has also driven global sales expansion through Sky’s network of distributor partners, supported by healthcare supply chains, such as the NHS supply chain, where the geko™ device is listed.
The data is also driving clinical practice nationally – an additional 20 NHS stroke units are actively working to embed the geko™ device into their acute stroke care pathways.
A study has also been conducted by a major NHS trauma centre, investigating use of the geko™ to reduce pre-operative oedema in ankle fracture patient requiring Open Reduction Surgical Fixation (ORIF), and compared the results to current standards of care. The geko™ device was fitted above the backslab plaster. The study measured patient compliance and readiness to surgery, matched to the historical cohort and reported a 2-day improvement in readiness to surgery per patient (average), good patient compliance and a cost saving of £569 per patient (average).
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