Summary

Summary

  • The technology described in this briefing is Danis stent. It is used to stop acute bleeding from oesophageal varices, which are a major complication of portal hypertension and mainly happen in people with underlying liver disease.

  • The innovative aspects are that it has a safety indicator balloon which prevents the gastric balloon from inflating in the oesophagus and aims to reduce the risk of balloon-related perforation. The company states that the stent can be inserted without image guidance, allowing rapid tamponade in acute scenarios.

  • The intended place in therapy would be as an alternative method to balloon tamponade or early transjugular intrahepatic portosystemic shunt in people with refractory oesophageal variceal bleeding, in accordance with existing clinical guidelines.

  • The main points from the evidence summarised in this briefing are from 6 studies including a total of 202 people with refractory variceal bleeding. They show that Danis stent is effective at controlling acute refractory bleeds as a bridging therapy to further treatment. Data from 1 randomised controlled study suggest it may be a more effective and safer method than balloon tamponade.

  • Key uncertainties around the evidence include the lack of extensive UK evidence which may limit generalisability to the NHS. Only 1 study was done in the UK and this was a case series study involving a small number of patients.

  • The cost of Danis stent is £1,495 per unit (basic procedure pack; excluding VAT). The company claims the technology has the potential to be resource releasing by reducing the need for high dependency hospitalisation. There is no published evidence to support these claims.