One of the things that Kirsty mentions in her article is the fact that the denervation procedure which uses similar devices to reach the kidneys was approved without extensive or independent clinical trials, the only trials were actually carried out by the manufacturer of the device:
Quote:
Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure.
http://www.vessixvascular.com/technology.html She goes on to say that this shows a clear case of double standards. A similar thing happened in the UK.
When we attended the first NICE meeting there was a person there representing the company who makes the catheters for the insertion of a valve into the aorta: TAVI (Transcatheter aortic valve implantation). TAVI has received guidance from NICE in March 2012, the same time as the guidance issued for CCSVI angioplasty. However the content of the guidance is very different:
Quote:
According to the NICE Interventional Procedure guidance (March 2012) TAVI can be offered routinely as a treatment option to patients with aortic stenosis who cannot have open heart surgery because of poor health or technical difficulties, provided that doctors are sure that:
the patient understands what is involved and agrees to the treatment, and
the results of the procedure are monitored
.
This is the kind of guidance that we would have loved to see issued for CCSVI treatment. It would have been much better for the pwMS who wanted to undergo this procedure to be able to get the treatment without the need for clinical trials, which are really difficult to carry out in the setting of a surgical procedure. Angioplasty for CCSVI is relatively safe, the TAVI procedure is highly risky... so why the discrepency in guidance. A clear case of double standards.
http://www.bmj.com/content/345/bmj.e4710/rr/598027
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