Regulatory Focus™ > News Articles > FDA: Use of Medical Device in MS Patients 'Unproven,' Risky

FDA: Use of Medical Device in MS Patients 'Unproven,' Risky

Posted 10 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) sent out a warning to health professionals on 10 May warning them of the dangers associated with the use of a balloon angioplasty device to widen narrowed veins in the chest and neck of patients suffering from Multiple Sclerosis (MS), saying the procedure was unproven and potentially deadly.

The balloon angioplasty devices have been used to experimentally treat chronic cerebrospinal venous insufficiency (CCSVI), which is characterized by the narrowing of veins and is thought by some to contribute to the progression of MS.

The procedure has not been approved by FDA for use in MS patients, and FDA's statement warned against patients using the unproven technique.

"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS," said William Maisel, deputy director for science at FDA's Center for Devices and Radiological Health.

A number of serious adverse events have been associated with the procedure, wrote FDA.

"[T]he FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure," the agency said in a statement.

FDA said in an accompanying statement it wants to emphasize to clinical investigators that all clinical trials need to conform to regulations governing investigational devices, including establishing a scientific link between CCSVI and MS, which would in turn establish defined clinical endpoints.

At present, the use of balloon angioplasty represents a significant risk study, and requires the approval of an institutional review board and an Investigational Device Exemption (IDE) from FDA.

Read more:

FDA - FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

FDA - FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

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