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New Surgery Technique Recommended For Parkinson's Treatment

Deep-brain stimulation (DBS), the innovative surgical technique that holds promise for thousands of PWPs here and around the world, has been recommended for conditional approval as Parkinson's therapy by a key government advisory panel.

The unanimous vote of the Neurological Device Panel Advisory Committee to the U.S. Food and Drug Administration came March 31 following a full day of public hearings attended by patients, voluntary associations, doctors and representatives.

The procedure, which involves the implantation in the brain of electrodes connecting a pacemaker-type device embedded in the patient's chest to that part of the brain where dopamine is produced, was developed by scientists in France using equipment known as Activa Parkinson's Control Therapy. The equipment is produced by Medtronic Inc, a Minneapolis-based manufacturer known best for its leadership in the development of pacemakers for the heart.

Originally tested in the areas of the brain known as the globus pallidus and the thalamus, where it was found effective in the control of tremor but not much else, Activa therapy the device has since been tried out in the adjacent area of known as the subthalamic nucleus. Here, the procedure has been found to help many patients in controlling other Parkinson's too, including rigidity, slowness of movement, and poor balance.

The conditions recommended by the panel included three-year clinical follow-up, including testing of cognitive and neuropsychological factors; physician instruction on selecting electrodes and programming; and several label changes.

Robin Anthony Elliott, PDF's executive director, who testified at the March 31 hearing, warmly supported the proposal to approve DBS and noted that the new surgeries --"thanks to modern technology, so much safer and more effective than their precursors" - are "vital new additions to the armory of anti-Parkinson's interventions." He also described Activa therapy, among those advanced-stage patients for whom it may be appropriate, as a true "quality-of-life belt."

He also cautioned that "in any high-tech procedure of the kind we are talking about, the safety and success depends in large part upon the experience of the medical personnel, the availability of such sophisticated and important services as brain-mapping, and the quality and scale of the institutional back-up." He recommended that people interested in exploring the suitability of Activa for themselves "check first with those medical centers that have specialized resources and personnel dedicated to the procedure."

Source Date: May 13 2000