Med Tech-related technology assessments and clinical guidelines from NICE in January 2019

28

Feb 2019

In January 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, three medical technologies guidance, and three new MedTech innovation briefings for liver function capacity test, a functional electrical stimulation (FES) integrated cycling system used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury, laser shoe attachment used as a walking aid and is designed to help prevent freezing of gait in people with Parkinson's disease.

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.

In January NICE published six new Interventional Procedure Guidance:

  • Interventional Procedure Guidance Ex-situ machine perfusion for extracorporeal preservation of livers for transplantation, which covers evidence-based recommendations on ex-situ machine perfusion for extracorporeal preservation of livers for transplantation in people of all ages. The evidence on ex-situ machine perfusion for extracorporeal preservation of livers for transplantation raises no major safety concerns. However, current evidence on its efficacy is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research
  • Interventional Procedure Guidance Platelet-rich plasma injections for knee osteoarthritis, which covers evidence-based recommendations on platelet-rich plasma injections for knee osteoarthritis in adults. Current evidence on platelet-rich plasma injections for knee osteoarthritis raises no major safety concerns. However, the evidence on efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research
  • Interventional Procedure Guidance Electrically stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer, which covers evidence-based recommendations on electrically stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer in adults. Current evidence on electrically stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer shows there are no major safety concerns. Evidence on efficacy is limited in quantity and quality. Therefore, this procedure should only be used in the context of research
  • Interventional Procedure Guidance Laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth, which covers evidence-based recommendations on laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth. Current evidence on the safety and efficacy of laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth 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 Percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis, which covers evidence-based recommendations on percutaneous venoplasty for chronic cerebrospinal venous insufficiency in people with multiple sclerosis. Current evidence on percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis shows that there are serious complications and that it provides no benefit. Therefore, this procedure should not be used in the management of multiple sclerosis
  • Interventional Procedure Guidance Prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia, which covers evidence-based recommendations on prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia in adults. Current evidence on the safety and efficacy of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia is limited 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 January NICE published three new Medical Technologies Guidance:

  • Medical Technologies Guidance Mepilex Border Heel and Sacrum dressings for preventing pressure ulcers covers evidence-based recommendations on Mepilex Border Heel and Mepilex Border Sacrum dressings (Mölnlycke Health Care) – self-adherent, 5-layer foam dressings that include a patented soft silicone technology (known as Safetac). Mepilex Border Heel and Sacrum dressings show promise for preventing pressure ulcers in people who are considered to be at risk in acute care settings. However, there is currently insufficient evidence to support the case for routine adoption in the NHS
  • Medical Technologies Guidance Senza spinal cord stimulation system for delivering HF10 therapy to treat chronic neuropathic pain covers evidence-based recommendations on Senza spinal cord stimulation (SCS) system (Nevro) – a neuromodulation device that delivers electrical impulses to the spinal cord. The case for adopting Senza spinal cord stimulation (SCS) for delivering HF10 therapy as a treatment option for chronic neuropathic back or leg pain after failed back surgery is supported by the evidence. HF10 therapy using Senza SCS is at least as effective as low‑frequency SCS in reducing pain and functional disability and avoids the experience of tingling sensations (paraesthesia). Senza SCS for delivering HF10 therapy should be considered for patients with residual chronic neuropathic back or leg pain (at least 50 mm on a 0 mm to 100 mm visual analogue scale) at least 6 months after back surgery despite conventional medical management, and who have had a successful trial of stimulation as part of a wider assessment by a multidisciplinary team
  • Medical Technologies Guidance UrgoStart for treating diabetic foot ulcers and leg ulcers covers evidence-based recommendations on UrgoStart (Urgo Medical) – an interactive dressing for treating diabetic foot ulcers and leg ulcers. Evidence supports the case for adopting UrgoStart dressings to treat diabetic foot ulcers and venous leg ulcers in the NHS because they are associated with increased wound healing compared with non-interactive dressings. UrgoStart dressings should, therefore, be considered as an option for people with diabetic foot ulcers or venous leg ulcers after any modifiable factors such as infection have been treated

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

Three new Medtech Innovation Briefings for LiMAx system for assessing the functional capacity of the liver (liver function capacity test, which intended to predict postoperative outcomes in people who are being considered for liver surgery or liver transplant), RT300 for spinal cord injury rehabilitation (a functional electrical stimulation (FES) integrated cycling system used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury), and  Path Finder for freezing of gait in people with Parkinson’s disease (laser shoe attachment used as a walking aid and is designed to help prevent freezing of gait in people with Parkinson's disease) have been published in January.

See full details here.

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