2.1 The geko device (FirstKind Ltd) is a battery powered, disposable neuromuscular electrostimulation device that is designed to increase venous blood flow, with the aim of reducing the risk of venous thromboembolism.
2.2 The geko device is portable, compact and resembles a small wristwatch. It is applied to the skin over the fibular head (or other application site) and held in position wrapped around the leg, below the crease of the knee. The device uses a patented electrical impulse delivery system. The impulses stimulate the common peroneal nerve, which causes muscular contractions in the lower leg and foot. The muscular action drives the venous muscle pump of the lower leg, facilitating the emptying of veins and increasing the return of blood to the heart. This is designed to imitate the process normally achieved by walking, without the person having to move.
2.3 The geko device is applied by a healthcare worker to 1 or both legs as needed. The device is non-invasive, small (149 mm × 42 mm × 11 mm) and lightweight (16 g), and does not restrict movement of the knee. The device is self-adhesive but an extra adhesive overlay is provided and used if necessary. The small contact area (35 cm2) of the device is designed to minimise skin irritation and sweating. This device is available in a single size which is claimed to be suitable for most people. The device is disposable and must be replaced every 24 hours.
2.4 The geko device received a CE mark as a class IIa medical device in October 2010, to increase blood circulation and for the prevention of venous thrombosis.
2.5 The list price stated in the sponsor's submission is £22 (excluding VAT) per pair of geko devices.
2.6 The claimed benefits of the geko device in the case for adoption presented by the sponsor are:
The geko device reduces the risk of venous thromboembolism via the prevention and reduction of venous stasis.
Good patient adherence due to ease of application, which could help with a faster recovery.
Discreet and comfortable to wear, allowing the person to retain their independence and mobility. This may help maintain patient wellbeing and ensure self-sufficiency.
Minimal skin contact and therefore avoidance of skin irritation, skin breakdown and sweating.
The geko device addresses an unmet need by delivering venous thromboembolism prophylaxis to patient groups who cannot use standard venous thromboembolism prophylaxis.
The potential to improve speed of patient recovery and therefore reduce the length of hospital stay.
2.7 Venous thromboembolism – reducing the risk (NICE clinical guideline 92, currently being partially updated in the light of new evidence on mechanical prophylaxis in patients who have had a stroke) recommends that all people admitted to hospital should have an assessment of their risk of venous thromboembolism. They should also have their risk of bleeding assessed before pharmacological prophylaxis is offered, and treatment should be determined by the balance of the risks of venous thromboembolism and bleeding occurring.
2.8 The choice of mechanical venous thromboembolism prophylaxis should be based on individual patient factors including clinical condition, surgical procedure and patient preference. Recommended methods of mechanical venous thromboembolism prophylaxis include anti-embolism stockings (thigh or knee length), foot impulse devices and intermittent pneumatic compression devices (thigh or knee length).
2.9 NICE clinical guideline 92 makes special reference to anti-embolism stockings and recommends that they should not be offered to people who have suspected or proven peripheral arterial disease, peripheral arterial bypass grafting, peripheral neuropathy or other causes of sensory impairment, cardiac failure, severe leg oedema or pulmonary oedema from congestive heart failure, major limb deformity preventing correct fit, local conditions in which stockings may cause damage (for example, 'tissue paper' skin, dermatitis, gangrene or recent skin graft) and unusual leg size or shape.
2.10 The guideline recommends offering combined venous thromboembolism prophylaxis with mechanical and pharmacological prophylaxis to people with major trauma or spinal injury, and to those having elective hip or knee replacement and hip fracture surgery. It also recommends consideration of combined venous thromboembolism prophylaxis for other orthopaedic surgery, based on assessment of risks and discussion with the patient, and for women who are pregnant or who have given birth during the previous 6 weeks who are having surgery, including caesarean section.