Med Tech-related technology assessments and clinical guidelines from NICE in August 2018

Interventional Procedure Guidance is developed for most of the novel interventional procedures entering the English market. The program focuses solely on the 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 August NICE published four new Interventional Procedure Guidance:

• Interventional Procedure Guidance Leadless cardiac pacemaker implantation for bradyarrhythmias, which covers evidence-based recommendations on leadless cardiac pacemaker implantation for bradyarrhythmias in adults. Evidence on the safety of shows that there are serious but well-recognised complications. The evidence on efficacy is inadequate in quantity and quality. For people who can have conventional cardiac pacemaker implantation, leadless pacemakers should only be used in the context of research. For people in whom a conventional cardiac pacemaker implantation is contraindicated following a careful risk assessment by a multidisciplinary team, leadless cardiac pacemakers should only be used with special arrangements for clinical governance, consent and audit or research.
• Interventional Procedure Guidance Superior rectal artery embolisation for haemorrhoids, which covers evidence-based recommendations on blocking the blood vessels supplying the haemorrhoids with tiny plastic particles or metal coils. Current evidence on the safety and efficacy of superior rectal artery embolisation for haemorrhoids is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
• Interventional Procedure Guidance Sutureless aortic valve replacement for aortic stenosis, which covers evidence-based recommendations on removing the narrowed aortic valve and replacing it with an artificial valve that holds itself in place for aortic stenosis in adults. Current evidence on the safety and efficacy of sutureless aortic valve replacement for aortic stenosis 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 Transurethral water vapour ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia, which covers evidence-based recommendations on using heated water vapour to destroy some of the prostate tissue for lower urinary tract symptoms caused by benign prostatic hyperplasia in adults. Current evidence on the safety and efficacy of transurethral water vapour ablation for urinary tract symptoms caused by benign prostatic hyperplasia is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.

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 a formal guidance, and it, therefore, does not provide any recommendations.

Four new Medtech Innovation Briefings for Rezum for treating benign prostatic hyperplasia (device uses steam to ablate prostate tissue with the aim of improving lower urinary tract symptoms secondary to benign prostatic hyperplasia), AlignRT in breast cancer radiotherapy (patient position monitoring system for breast cancer radiation therapy), NephroCheck test to help assess the risk of acute kidney injury in critically ill patients (in vitro diagnostic test used to measure urinary biomarkers of kidney injury as an aid in detecting acute kidney injury) and Neon EEG electrode for EEG monitoring in newborns (EEG electrode used for electroencephalogram (EEG) monitoring in newborns) have been published in August.

See full details here.

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