News Alert: The geko™ device receives FDA 510(k) for edema reduction supporting entry in the USA. Read The Full Press Release
What is the geko™?
Powered by OnPulse™ technology, the non-invasive geko™ device triggers the body's built in mechanisms to increase blood circulation. Small electrical impulses gently stimulate the common peroneal nerve which in turn activates the muscle pumps of the lower leg that return blood towards the heart. In this way, neuromuscular stimulation in the lower limb emulates the process normally achieved by walking (up to 60%) but without the patient having to move or exert energy and without discomfort.
A simple, self-adhesive device that is applied to the back of each knee, the disposable, one-size-fits-all geko™ device is designed to avoid the need for more complex procedures.
Instruction For Use
How to use the geko™?
Disposable, self-contained geko™ device:
- quick and easy to apply — it takes just 60 seconds to fit
- simple to operate — from just one button
After simple preparation of the skin, the geko™ device is applied via its self-adhesive gel to the outside of the leg, just below the level of the knee, at the center of the fibula head. The fibula head can be felt as a round protrusion at the very top of the fibula bone. Alternatively the device may be applied to the back of the knee. Positioned correctly, it sits just above or just below the crease with its operating button located conveniently to the outer side of the leg at the knee.
Easy to wear, the geko™ device is designed to increase blood flow in a range of conditions. Small, light and comfortable, it allows full freedom of movement and, adjustable to match patient sensitivity, its operation can be hardly noticeable. Set up for up to 24 hour use, the disposable geko™ device is designed to be safe and hygienic.
Who uses the geko™?
The geko™ device may be used by anyone who might benefit from increased, lower limb circulation and a reduction of blood stasis.
The geko™ device emulates the process normally achieved by walking (up to 60%) without the patient having to move or exert energy and without uncomfortable muscle movements.
The geko™ T-2 neuromuscular stimulator device is intended for:
- Increasing local blood circulation
- Reduce risk of Deep Vein Thrombosis
- Prevention of VTE
- Edema Reduction
The aim of this study was to analyse the impact of the geko™ device on blood flow in the deep veins of the calf in healthy individuals. The deep veins of the calf is where early thrombi (DVT) are often thought to form after a period of deep vein blood stasis which is common during periods or immobility or trauma. Proving that the geko™ device prevented deep vein stasis would be clinically significant in the management of this indication.
Learn more about the VTE Prophylaxis Study.
Deep Vein Thrombosis
The geko™ device can prevent Deep Vein Thrombosis (DVT)
The geko™ device has been reviewed by the UK National Institute for Health and Clinical Excellence (NICE) medical technology evaluation program (MTEP) as anti-stasis/DVT prophylaxis solution to specific groups of patients who cannot be served by existing modalities.
The recommendations are:
- The case for adopting the geko™ device is supported for use in people who have a high risk of venous thromboembolism and for whom other mechanical and pharmacological methods of prophylaxis are impractical or contraindicated.
- The case is supported because of the plausibility that the geko™ device may reduce the high risk of venous thromboembolism in patients who cannot use other forms of prophylaxis, and the low risk of the device causing harm.
In the US the geko™ is indicated for the immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The benefits of using geko™
The chart below compares the ease of use of geko™ devices with other devices currently in use that are intended to perform a similar role taken from a recent Device Comparison Study - principal investigators Dr. Arthur Tucker and Dr. Annelie Maass, The Ernest Cooke Vascular & Microvascular Unit, St. Bartholomew's Hospital.
Current DVT prophylaxis
There are several significant disadvantages of the two current methods against which geko™ compares favorably should it be of proven use in the prevention of DVT.
Disadvantages of pharmacological treatment:
- active bleeding
- allergic reactions
- risk of VTE persists for weeks or months after hospital discharge
- drug interactions with several substances, e.g. antibiotics, food
- level of clinical supervision required
Disadvantages of mechanical treatment (Intermittent Pneumatic Compression and Graduated Elastic Compression Stockings):
- uncomfortable to wear
- range of sizes required
- external power source required, restricting patient's mobility (IPC)
- poor compliance
Providing post-surgical venous thromboembolism (VTE) prophylaxis
The geko™ is a battery powered, disposable, neuromuscular electrostimulation device designed to increase blood flow in the deep veins of the leg2, reducing the risk of VTE.
The geko™ device stimulates the common peroneal nerve activating the calf and foot muscle pumps, increasing venous, arterial and microcirculatory blood flow3,4. The increase in blood flow is similar to that achieved by walking, equal to 60%3, without a patient having to move3.
The geko™ device prevents stasis in the deep veins of the calf where early thrombi form.
The publication of a recent study by Professor Andrew Nicolaides and Dr Maura Griffin has measured the effect of the geko™ device on blood flow in the deep veins of the calf. The study has shown significant volume and velocity increases within the gastrocnemius, peroneal and posterior tibial veins — of particular clinical importance as early thrombi often form in these veins2.
This is the first time that a mechanical device has reported enhancement to blood flow for the prevention of stasis in the deep veins of the calf, and is the result of the unique dorsiflexion achieved by the geko™ device. With this proven ability to prevent stasis in the deep veins of the calf, the study strongly supports use of the geko™ device for VTE prevention. The four Doppler flow readings (below) clearly validate the muscle contraction and rhythmic blood flow increases before and after geko™ device application and show distinct increases in both peak volume and velocity.
The peroneal vein
The image clearly validates the muscle contraction resulting from the applied geko™ device. The results show the rhythmic increases in peroneal venous flow which would otherwise show low flow states without the use of the device.
The gastrocnemius vein
The venous colour filling highlights the rhythmic muscle contractions resulting from the application of the geko™ device. The gastrocnemius vein (top of the image) emptying into the popliteal vein (middle of the image) with the popliteal artery lying posterior to the popliteal vein.
The posterior tibial vein
The geko™ device increases venous blood flow through neuromuscular activation via the common peroneal nerve. Figure 3 shows the baseline Doppler flow pattern typical of venous flow.
The posterior tibial vein
After the activation of the geko™ device, the Doppler flow pattern shows a distinct increase in not only peak velocity but overall flow too (Figure 4).
- NICE medical technologies guidance [MTG19] Published date June 20 2014
- A.Nicolaides, M Griffin, Measurement of blood flow in the deep veins of the lower limb using the geko™ neuromuscular electro-stimulation device. Journal of International Angiology August 2016-04
- Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, et al. Augmentation of venous, arterial and microvascular blood supply in 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
- Jawad, H., Bain, D., Dawson, H., Crawford, K., Johnston, A., Tucker, A.T. The effectiveness of a novel neuromuscular electrostimulation method versus intermittent pneumatic compression in enhancing lower limb blood flow. 2014 Journal Vasc Surg. Vol 2, No 25
Post-operative Edema Reduction
Clinically proven to accelerate readiness for theatre in patients requiring Open Reduction Internal Fixation (ORIF).
Pre-operative edema can often delay surgical fixation for ankle fracture patients due to risks associated with operating on swollen tissue. The current standards of care for managing readiness for theatre include leg elevation in combination with a back-slab plaster cast.
A prospective and retrospective study, completed by a NHS trauma center, investigated the use of geko™ to reduce pre-operative edema in ankle fracture patients and compared the results to the current standards of care.
The study recruited ankle fracture patients requiring surgical fixation. The device was fitted above their backslab plaster casts. Patent compliance and readiness for theatre was recorded and matched to a historical cohort for comparison.
The study data was statistically significant: P=0.0011, and the geko™ device was reported as well tolerated and easy to use.
- 2 days improvement in readiness for theatre
- With geko™ use, 60% of patients ready for theatre in 2 days, compared to 27% in control arm, a 122% improvement
- Current treatment = 3.66 days readiness to theatre (average)
- The geko™ + plaster cast = 1.66 days readiness to theatre (average)
Health economic analysis shows that compared to the current standards of care, routine use of a backslab plaster cast + the geko™ device:
- Saves an average of $800.00 per patient
- The geko™ device accelerates reduction of edema 2
- Wainwright TW, Immins T, Middleton RG, Poster Physiotherapy UK, October 2o14, Birmingham.
- Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, et al. Augmentation of venous, arterial and microvascular blood supply in 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.
- Klabunde, RE (2014). Cardiovascular Physiology Concepts. Available at: http://cvphysiology.com/Microcirculation/M010 [Accessed 21 Feb. 2018].
Deep Vein Thrombosis Study
Augmentation of venous, arterial and micro-vascular blood supply in the leg…, The use of OnPulse™ for neuromuscular electrostimulation of the muscles in the lower leg…
Blood Flow in a Below-knee Cast
Neuromuscular electrostimulation via the common peroneal nerve promotes lower limb blood flow in a below-knee cast., A potential for thromboprophylaxis.
IPC Device vs NMES Device
The effect of calf neuromuscular electrical stimulation and IPC…, In comparison to the IPC device, the NMES device significantly increases cutaneous blood flow…