Vascular Expert Supports FDA Warning About Experimental Therapy for MS Patients
Published: May 14, 2012
Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute in Miami, advocates a controlled clinical trial to obtain credible evidence that the experimental procedure to treat chronic cerebrospinal venous insufficiency (CCSVI) is beneficial for MS. The FDA reported injuries and death related to the therapy.
“Any new treatment like this gives hope to people with multiple sclerosis. Because it is a high-risk procedure, we need new clinical trials to obtain evidence that confirms it is truly effective in treating multiple sclerosis,” said Dr. Katzen, who has performed the procedure in other instances.
Some researchers believe that CCSVI, distinguished by a narrowing of veins in the neck and chest, either may cause or contribute to MS by blocking blood flow from the brain and upper spinal cord.
The FDA warned researchers who use balloon angioplasty devices and stents for widening the veins they must comply with FDA regulations for investigative trials. Clinical studies considered to be high risk require the necessary FDA approval, called an investigational device exemption.
For Baptist Cardiac & Vascular Institute in Miami
Melissa Lichtenheld, 305-372-1234