Med Tech-related technology assessments and clinical guidelines from NICE in the second half of July 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 the second half of July NICE published five new Interventional Procedure Guidance:

• Interventional Procedure Guidance Low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing provides evidence-based recommendations on low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing in adults. this procedure should not be used for this indication as the evidence for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing raises no major safety concerns, however, current evidence does not show efficacy
• Interventional Procedure Guidance Low-intensity pulsed ultrasound to promote healing of fresh fractures at high risk of non-healing provides evidence-based recommendations on using an ultrasound probe on the skin at the site of the fracture to promote healing of fresh fractures at high risk of non-healing in adults. The evidence for procedure raises no major safety concerns. The current evidence on efficacy is very limited in quantity and quality. Therefore, this procedure should only be used in the context of research
• Interventional Procedure Guidance Low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures provides evidence-based recommendations on low-intensity pulsed ultrasound to promote healing of delayed-union and non-union fractures in adults. The evidence for procedure raises no major safety concerns. The current evidence on efficacy is inadequate in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research
• Interventional Procedure Guidance Superior capsular augmentation for massive rotator cuff tears provides on superior capsular augmentation for massive rotator cuff tears in adults. Current evidence on the safety and efficacy of superior capsular augmentation for massive rotator cuff tears is limited in quantity and inadequate in quality. Therefore, this procedure should only be used in the context of research
• Interventional Procedure Guidance Transaxial interbody lumbosacral fusion for severe chronic low back pain provides evidence-based recommendations on removing a damaged disc through a small cut at the base of the spine, and replacing it with an artificial implant. Evidence on the safety of transaxial interbody lumbosacral fusion for severe chronic low back pain shows that there are serious but well-recognised complications. Evidence on efficacy is adequate in quality and quantity. Therefore, this procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit.

Two new Medtech Innovation Briefing for Remote ECG interpretation consultancy services for cardiovascular disease (it is used for assisting in diagnosing and decision-making for people with cardiovascular disease) and Mechanical thrombectomy devices for acute ischaemic stroke (21 mechanical thrombectomy devices of 2 types, including stent retrievers and aspiration catheters, are described) have been published in the second half of July.

See full details here.

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