Med Tech-related evaluations from NICE in June 2019

In June 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, one new Medical technologies guidance for Endocuff Vision for assisting visualisation during colonoscopy, and two new MedTech innovation briefings (for Danis stent for acute oesophageal variceal bleeds, and The OPTIMIZER smart system for managing heart failure).

Interventional Procedure Guidance 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.

In June 2019, NICE published six new Interventional Procedure Guidance:

• Interventional Procedure Guidance Percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI, which covers evidence-based recommendations on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI in adults. The evidence on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI raises no major safety concerns other than those associated with the TAVI procedure. However, the evidence on efficacy for preventing TAVI-related stroke is inconclusive. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research
• Interventional Procedure Guidance Percutaneous mechanical thrombectomy for acute deep vein thrombosis of the leg, which covers evidence-based recommendations on percutaneous mechanical thrombectomy for acute deep vein thrombosis of the leg in adults. Current evidence on the safety of percutaneous mechanical thrombectomy for acute deep vein thrombosis (DVT) of the leg shows there are well-recognized but infrequent complications. For acute iliofemoral DVT, the evidence on efficacy is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. For distal DVT that does not extend into the common femoral vein, the evidence on efficacy is inconclusive. Therefore this procedure should only be used in the context of research.
• Interventional Procedure Guidance Bronchoscopic thermal vapor ablation for upper-lobe emphysema, which covers evidence-based recommendations on bronchoscopic thermal vapor ablation for upper-lobe emphysema in adults. Current evidence on the safety and efficacy of bronchoscopic thermal vapor ablation for upper-lobe emphysema is inadequate in quantity and quality. Therefore the procedure should only be used in the context of research
• Interventional Procedure Guidance Valve-in-valve TAVI for aortic bioprosthetic valve dysfunction, which covers evidence-based recommendations on valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) for aortic bioprosthetic valve dysfunction in adults. Current evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) for aortic bioprosthetic dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent, and audit
• Interventional Procedure Guidance Reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia, which covers evidence-based recommendations on reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia. The evidence on the safety of reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia shows there are serious but well-recognized complications. The evidence on efficacy is limited in quantity and quality. Therefore, this procedure should not be used unless special arrangements are in place for clinical governance, consent, and audit or research
• Interventional Procedure Guidance Cardiac contractility modulation device implantation for heart failure, which covers evidence-based recommendations on cardiac contractility modulation device implantation for heart failure in adults. The evidence on cardiac contractility modulation device implantation for heart failure raises no major safety concerns. However, the evidence on efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research

Medical technologies guidance evaluates new, innovative medical devices, and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients or detect or monitor medical conditions.

In June 2019, NICE published one new Medical Technologies Guidance:

• Medical Technologies Guidance Endocuff Vision for assisting visualization during colonoscopy covers evidence-based recommendations on Endocuff Vision – a single-use, disposable device which fits over the end of most conventional colonoscopes. Evidence supports the case for adopting Endocuff Vision in the NHS because it improves the adenoma detection rate during colonoscopy, particularly for people having a colonoscopy as part of bowel cancer screening.

Endocuff Vision should be considered as an option for people having a colonoscopy as part of bowel cancer screening following a positive stool test. There is limited evidence for the benefits of Endocuff Vision in a non-screening population.

MedTech Innovation Briefing 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.

Two new Medtech Innovation Briefings for Danis stent for acute oesophageal variceal bleeds (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) and The OPTIMIZER smart system for managing heart failure (a programmable cardiac stimulation device for people with chronic heart failure) have been published in June.

See full details here.

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