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MedTech-related technology assessments and clinical guidelines from NICE in August 2022
Interventional Procedures 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.
In August 2022, NICE published five new IPGs and made the following conclusions:
- Evidence on the safety and efficacy of aortic remodelling hybrid stent insertion during surgical repair of an acute type A aortic dissection is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
- Evidence on the efficacy of bioresorbable stent implantation to treat coronary artery disease is inadequate. Evidence on its safety has shown an increased risk of serious complications in the longer term, including an increased risk of myocardial infarction and death with some types of bioresorbable stents. Therefore, this procedure should only be used in the context of research;
- Evidence on the safety of superficial venous arterialisation for chronic limb threatening ischaemia shows well-recognized complications. Evidence on its efficacy is inadequate in quantity and quality. However, in people with no other option for revascularisation, this procedure can be used with special arrangements for clinical governance, consent, and audit or research;
- Evidence on the safety of transcutaneous electrical neuromuscular stimulation for urinary incontinence raises no major concerns. Evidence on its efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
- Evidence on the efficacy of focal resurfacing implants to treat articular cartilage damage in the knee is limited in quality and quantity. Short-term evidence shows no major safety concerns, but long-term evidence on safety is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
The MedTech Innovation Briefings (MIBs) is the advice program of NICE 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. Three new MIBs published in August 2022 are:
- Stockholm3 for prostate cancer screening is a blood-based diagnostic test that is to be used alongside prostate-specific antigen (PSA) testing to predict the risk of prostate cancer in people aged 45 to 74 years with no previous prostate cancer diagnosis;
- Differential target multiplexed spinal cord stimulation (DTM SCS) for chronic lower back and leg pain. The technology is based on a proprietary algorithm that is programmed into the Intellis neurostimulator. It represents a novel SCS waveform that targets multiple anatomical locations using multiple electrical signals.
- Contrast-enhanced spectral mammography (CESM) for breast cancer is a technique that combines mammography with contrast enhancement to show breast cancers that may not be visible on standard mammography. This briefing focuses on four products capable of CESM: Senographe Pristina, 3Dimensions, AMULET Innovality, and MAMMOMAT Revelation.
Medical Technologies Guidance (MTG) 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 August 2022, NICE updated two MTGs:
- SecurAcath for securing percutaneous catheters, initially published in 2017. Updates were made to reflect 2021 costs and revise cost-saving estimates;
- iFuse for treating chronic sacroiliac joint pain, initially published in 2018. The amended guidance includes iFuse-3D, a second-generation 3D-printed implant, and updated costs.
Two clinical guidelines were updated in August 2022:
- Lung cancer: diagnosis and management - updates concerned pharmacotherapy only;
- Type 1 diabetes in adults: diagnosis and management - recommendations on blood pressure targets were amended.
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