Medtech innovation briefings and Interventional Procedure Guidance from NICE in August 2019

In England, the National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. It develops interventional procedure guidance, med-tech innovation briefings, clinical guidelines, etc.

Interventional Procedure Guidance (IPG) is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from ‘for research only’ to ‘for use with standard arrangements for clinical governance, consent, and audit.' Recommendations are not binding, although they are followed by providers and commissioners.

Two new IPGs were released by NICE in August 2019:

• Endovascular insertion of an intrasaccular wire-mesh blood-flow disruption device for intracranial aneurysms (IPG658) with the following recommendations provided:
  • Current evidence on the safety and efficacy is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent, and audit
  • Patient selection should be done by a multidisciplinary team, except for emergencies, when an interventional neuroradiologist and neurosurgeon could be involved
  • The procedure should only be done in specialized centers with expertise in the use of this technology and access to neurosurgical facilities
• Low-energy contact X-ray brachytherapy (the Papillon technique) for locally advanced rectal cancer (IPG659) with the following recommendations provided:
  • Current evidence on safety and efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research
  • Further research should include randomized controlled trials comparing this procedure with standard care and report details of patient selection (including tumor type and suitability for surgery), patient-reported outcomes, quality of life, and long-term outcomes

Medtech Innovation Briefing (MIB) is the NICE's advice program for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

One new MIB was released by NICE in August 2019:

• Endo-SPONGE vacuum therapy for colorectal anastomotic leakage (MIB188) with the following vital conclusions provided:
  • The innovative aspects are that the technology uses a sponge, vacuum therapy and drainage in a minimally invasive way
  • The main points from the evidence show that Endo-SPONGE may help improve healing of colorectal anastomotic leaks without the need for surgery
  • Key uncertainties  are that no studies are comparing Endo‑SPONGE with other treatments for colorectal anastomotic leakage and no studies done in the NH
  • The cost of Endo-SPONGE (plus Redyrob drainage bottle) is £271.11 per unit (exclusive of VAT). The resource impact may be less than standard care because of reduced length of stay and a reduced need for reoperations and stomas

See the full information in English here.

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