NICE opens consultations on two medical devices set to benefit patients and the NHS


In draft guidance issued today, NICE provisionally supports the PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites and the Pipeline Embolization Device which is used to treat unruptured giant or complex intracranial aneurysms.

 Evidence demonstrates that using the PleurX system can improve patients’ quality of life for those with treatment-resistant, recurrent malignant ascites, that it is clinically effective, and has a low complication rate. The device fits into the abdomen wall, and enables the fluid to drain out via a catheter into a vacuum flask. One important benefit of the Pleurx system is that the fluid can be drained at home as needed, and there is no need to wait for a large volume to build up so it can be removed in hospital as is currently the case. The system is also likely to save the NHS around £679 per patient compared with inpatient large-volume paracentesis (fluid drainage).

In separate draft guidance also issued today, NICE provisionally supports the Pipeline Embolization Device. Evidence shows that there is a case for adopting the Pipeline Embolization Device in the NHS when it is used in patients with giant or complex intracranial aneurysms who would need large numbers of coils during stent assisted coiling and who are unsuitable for neurosurgical treatment. The Pipeline Embolization Device is a self-expanding blood flow diverter that is placed across the neck of an intracranial aneurysm. It is a stent-like device which is loaded into and delivered via a microcatheter. Once in place, the blood flow through the parent vessel continues through the device, but it cuts off blood flow to the aneurysm sac. The blood remaining in the blocked-off aneurysm forms a clot and it is eventually excluded from the circulation.


The information presented by the sponsor claims that using the Pipeline Embolization Device can reduce the symptoms caused by pressure of the bulging blood vessel on the brain. In addition, the Pipeline embolisation device may be the only feasible treatment for some patients with giant or complex intracranial aneurysms which are unsuitable for treatment with standard methods or surgery. The system is also likely to save the NHS around £421 per procedure compared with standard treatment.

In line with the standard NICE process, both sets of draft medical technology guidance have been issued for consultation and comments on the draft recommendations are welcomed.

The consultation on “PleurX peritoneal catheter drainage system for vacuum assisted drainage of treatment-resistant recurrent malignant ascites” and the consultation on “Pipeline embolisation device for the treatment of complex intracranial aneurysms” will both close at 5pm on 18 December 2011.