By Bernard Ross, Founder & CEO at Sky Medical Technology
SHOCK TO THE SYSTEM
Every 37 seconds someone in the western world dies from a venous thromboembolism (VTE). 55-60 per cent of all VTE cases occur during or following hospitalisation, with VTEs in hospitalised patients resulting in an estimated 40,000 deaths in England every year – 62 per cent of which are preventable given proper management. Stroke numbers are set to rise by almost 44% in the next 20 years. Action on stroke is therefore an acknowledged priority as part of NHS England’s Long-Term Plan announced in May 2019.
The issue is exacerbated by the fact patients that have experienced illnesses such as a stroke have a significantly increased risk of VTE because they have reduced mobility during the recuperation period. Despite this, VTE is often overlooked as a major public health problem.
Currently, many practitioners use intermittent pneumatic compression (IPC) devices to help prevent blood clots in the deep veins of the legs. These devices use cuffs around a patient’s legs that fill with air and squeeze – something research has shown a third of patients find intolerable. While the use of anti-coagulant drugs is not recommended by NICE due to unpredictable bleed risk.
Hyper-acute stroke patients contraindicated to IPC (e.g. through vascular or skin disease) or because they are intolerant of it, are in need of an alternative intervention to prevent venous stasis. This is especially critical given that high-risk and immobile patients (unable to be prescribed drugs) would have no other mechanical VTE prevention available to them other than standard measures of hydration and aspirin.
The baseline VTE incident risk of this unmet need (no IPC, plus standard measures) is 8.7%.
THE RISE OF BIOELECTRONICS
New drug development is an extensive process and one which rarely results in pharmaceutical medicines that radically improve patient outcomes. In comparison, recent years have seen significant advances in bioelectronic medicine – capable of offering impactful non-drug therapies to address a wide number of clinical applications. The appeal of these new device-based treatments is twofold: they are designed to hone in on and target specific nerves (as opposed to all cells) to stimulate or restrict certain actions in the body; and are already improving outcomes for patients with chronic circulatory conditions, cardiovascular disease and post-surgical complications related to swelling.
One example is the geko™, a wearable bioelectronic device, which is the size of a wristwatch and strapped to the lower leg. It 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% of walking. It requires no external compression of the leg and enables patients to be mobile while wearing the device. The geko™ is the first bioelectronic device of its kind to receive both NICE and FDA clearance and is trailblazing care pathway transformation for patients all over the world.
A ROYAL RESULT
Bioelectronic medicine devices have been shown in a number of studies to be effective when it comes to increasing blood flow and reducing VTE risk in high risk patients.
Sky Medical Technology has proven, through real-world clinical data, generated in partnership with the Royal Stoke University Hospital NHS trust, that the geko™ can address the critical unmet need of acute stroke VTE prevention. A comparison study of 1,000 hyper-acute stroke patients had their contraindication or intolerance to IPC reviewed and quantified. This audit showed that 68.8% of patients were in need of IPC but 29.5% of these patients were either contraindicated or were unable to tolerate this intervention, revealing a significant unmet need for an alternative anti-stasis (blood clot prevention) intervention.
The data shows that, of the 463 patients treated with IPC, 11 patients (or 2.4%) suffered a VTE event. Of the 203 patients treated with geko™ (to serve the unmet need) there was no incidence of VTE reported. The patients prescribed the geko™ also showed no adverse events or skin irritation and patients reported having a greater tolerance of the geko™ device than IPC. Furthermore, the geko™ device provided an option where previously patients would have had no other intervention available to them, ensuring no immobile stroke patient, with a high risk if VTE, was without a mechanical intervention.
The geko™ device was also reported as quick to fit and easy to use, and has significantly changed clinical practise at the Royal Stoke – and across 27 other NHS trusts who are now working to adopt the geko™ into their acute stroke pathways, having been convinced by the study data. The geko™ is also cost saving at £334 per patient, providing an annual saving of £67,802 per patient pa, and an overall saving to the NHS of £6.7m.
INVESTING IN SUCCESS
The medical devices market is predicted to be worth more than $6 billion in 2020, growing rapidly to $8.5 billion by 2025 – with bioelectronic medicine being one of the fastest growing areas of healthcare.
By treating conditions where there is currently an unmet need, devices like the geko™ can benefit 44 million patients worldwide today. But as the technology evolves further, bioelectronic devices could eventually be used to treat all acute and chronic circulatory conditions – improving the lives of more than 200 million patients and reducing the strain on health services with finite resources.
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