The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.
The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.
King's Technology Evaluation Centre, London, UK, jennifer.a.summers@kcl.ac.uk.
Jennifer A
JA
Summers
James
J
Clinch
Muralikrishnan
M
Radhakrishnan
Andy
A
Healy
Viktoria
V
McMillan
Elizabeth
E
Morris
Tiago
T
Rua
Mercy
M
Ofuya
Yanzhong
Y
Wang
Paul W
PW
Dimmock
Cornelius
C
Lewis
Janet L
JL
Peacock
Stephen F
SF
Keevil
D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004739:England; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply; D017410:Practice Guidelines as Topic; D013673:Technology Assessment, Biomedical; D054556:Venous Thromboembolism / Q000517:prevention & control*