Med Tech-related technology assessments and clinical guidelines from NICE in October 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 October NICE published one new Interventional Procedure Guidance:

• Interventional Procedure Guidance Selective internal radiation therapy for unresectable primary intrahepatic cholangiocarcinoma, which covers evidence-based recommendations on injecting tiny radioactive ‘beads’ into blood vessels that supply the liver, where they become trapped and release radiation directly into the cancer cells. Current evidence on the safety of selective internal radiation therapy (SIRT) for unresectable primary intrahepatic cholangiocarcinoma shows that there are well-recognised, serious but rare safety concerns. Evidence on its 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 October NICE published one new and oune updated Medical Technologies Guidance:

• Medical Technologies Guidance E‑vita open plus for treating complex aneurysms and dissections of the thoracic aorta covers evidence-based recommendations on E-vita open plus plus (JOTEC GmbH) – an endoluminal stent graft system designed for treating aneurysms and dissections of the thoracic aorta. The case for adopting the E‑vita open plus for treating complex aneurysms and dissections of the thoracic aorta, in a carefully selected group of people, is supported by the evidence. Using the E‑vita open plus could remove the need for a second procedure and the associated risk of serious complications, and it should therefore be considered for people who would otherwise need a 2-stage repair procedure because their aortic disease extends into or beyond the distal part of their aortic arch (into the proximal descending aorta), bu twho would not need additional intervention (such as stent grafting) in the descending aorta.
• Medical Technologies Guidance iFuse for treating chronic sacroiliac joint pain covers evidence-based recommendations on iFuse implant system (SI‑Bone) – a titanium implant intended for use in people with chronic sacroiliac joint pain. The case for adopting the iFuse implant system to treat chronic sacroiliac joint pain is supported by the evidence. Using iFuse leads to improved pain relief, better quality of life and less disability compared with non-surgical management. iFuse should be considered for use in people with a confirmed diagnosis of chronic sacroiliac joint pain (based on clinical assessment and a positive response to a diagnostic injection of local anaesthetic in the sacroiliac joint) and whose pain is inadequately controlled by non-surgical management.

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.

Three new Medtech Innovation Briefings for Servo-n with Neurally Adjusted Ventilatory Assist (NAVA) for babies and children (device used for babies and children up to 30 kg who need mechanical ventilation), gammaCore for cluster headache (handheld, patient-controlled, non-invasive vagus nerve stimulator used for preventing and treating cluster headaches) and myAIRVO2 for the treatment of chronic obstructive pulmonary disease (system that delivers warmed and humidified respiratory gases, including at high-flow rates) have been published in October.

See full details here.

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