NICE gives green light to balloon catheter, in first medical technology guidance
NICE has approved the use of a balloon catheter for use in coronary artery surgery, in the first ever piece of guidance from its new medical technology programme.
The final guidance - out this month - recommends the use of the SeQuent Please balloon catheter for patients with restenosis, a condition where the blood vessels become blocked again following a previous treatment with a stent.
The SeQuent Please balloon catheter consists of balloon angioplasty, a surgical procedure to widen blocked or narrowed coronary arteries, and local delivery of the drug paclitaxel to treat the part of the artery affected.
The treatment can help patients by relieving angina symptoms, reducing the risk of symptoms recurring and the incidence of restenosis.
This latest guidance recommends that SeQuent Please be considered for use in patients with in-stent restenosis in bare metal coronary artery stents, and in patients with other types of stent where there are clinical reasons to minimise how long clopidogrel treatment is used.
It should also be considered as an option for use in patients in whom it isn't technically possible to insert further stents.
This first medical technology guidance was produced by the Medical Technologies Advisory Committee (MTAC), which is part of the Evaluation Pathway Programme for Medical Technologies.
The programme was established in November 2009 to focus specifically on the evaluation of innovative medical technologies.
Its purpose is to produce guidance on the use of devices and diagnostics to speed up the introduction into the health service of those products offering significant benefits, or helping technologies to be investigated more thoroughly in research.
In particular, MTAC looks at whether a device offers benefits to the patient and NHS at a lower cost compared with similar products, or increased benefits for equal cost.
After the first year of use, SeQuent Please balloon catheter is associated with an annual estimated cost saving to the NHS of nearly £485,000, compared with standard therapy.
MTAC concluded that reductions in the number of cases of restenosis requiring medical treatment, readmission and repeat surgery would have future cost savings, if these effects were maintained in the long term.
Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation,said: “We are delighted to publish this first medical technology guidance - it's an important milestone both for NICE and the organisations we've worked with closely in establishing the new program to evaluate medical technologies.
“This positive guidance advises the NHS that SeQuent Please balloon catheter should be considered for use in patients with in-stent restenosis in specific circumstances.
“The evidence considered indicates that SeQuent Please balloon catheter may benefit patients and the NHS in the long term by reducing the number of cases requiring further treatment for restenosis.
“We hope that the NHS will find that our new pieces of medical technology guidance will help provide clarity on innovative devices that provide good-value improvements to patient care,” added Dr Longson.
NICE is now keen for more manufacturers to notify the Institute of any devices or diagnostics that could be considered by the Evaluation Pathway Programme.
Click here to complete a notification form.
6 December 2010