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Med Tech-related technology assessments and clinical guidelines from NICE in November 2020
In November, NICE published one new interventional procedures guidance for a swallowable gastric balloon capsule for weight loss.
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.
Evidence on the safety of the swallowable gastric balloon capsule for weight loss shows infrequent but potentially serious adverse events.
- For people who need to lose weight in the short term for medical reasons, the evidence of efficacy is adequate to support the use of this procedure provided that special arrangements are in place for clinical governance, consent, and audit
- For people who are aiming for long-term weight loss, the evidence on efficacy is inadequate in quantity and quality, so the procedure should only be used in the context of research
Further research could be in the form of randomized controlled trials comparing the procedure with current standard therapies or an observational cohort study, including using registry data. Studies should include details of patient selection such as body mass index and other treatments such as diet and lifestyle changes. The studies should also report short- and long-term weight loss, quality of life; metabolic parameters; the need for later surgery.
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.
Five MedTech Innovation Briefings were published in November:
- ClearGuard HD Antimicrobial Barrier Cap for preventing haemodialysis catheter-related bloodstream infections - central venous catheter cap with chlorhexidine acetate coated rod and cap threads
- Dexcom G6 for real-time continuous glucose monitoring – for measuring interstitial fluid glucose levels in people with type 1 or type 2 diabetes, using a sensor inserted under the skin
- NPi-200 for pupillary light reflex in critical care patients - to measure pupillary light reflex and pupil diameter in patients in critical care
- Magseed for locating impalpable breast cancer lesions - a localization technique that uses magnetic markers to mark the site of a breast cancer lesion for surgical removal, which is more flexible and less intrusive than a wire-guided procedure
- QuickChange Incontinence Wrap for urinary incontinence in men - prevents contact between urine and the skin and can be changed in under 30 seconds without lifting or rolling the person
Also, one clinical guidance for Acute coronary syndromes was updated in November. This guideline covers the early and longer-term (rehabilitation) management of acute coronary syndromes. This guideline provides new and updated recommendations, including percutaneous coronary intervention, stenting, and coronary angiography
See the full details here.
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