A complete transcript will be available at:
The Neurological Devices Panel (the Panel) met on Friday, March 31, 2000 to make recommendations to the Food and Drug Administration (FDA) on the approvability of a Medtronic, Inc. premarket approval application (PMA) supplement for the Activa® Deep Brain Stimulator Parkinson’s Control System. The company is seeking approval for six indications for bilateral deep brain stimulation. The original PMA was approved in 1997 for unilateral treatment Parkinson’s tremor and essential tremor.
The Panel heard testimony from two Parkinson’s disease patients, two Parkinson’s disease patient advocacy organizations, and two physicians. The sponsor presented information on the safety and effectiveness of the device, and FDA reviewers summarized the agency’s concerns about the PMA supplement. Three Panel members, a neurosurgeon, a neurologist, and a statistician, gave their perspectives on the surgical and medical treatment of Parkinson’s disease and the sponsor’s information. After deliberations on the information in the submission, the Panel considered FDA’s questions. The Panel recognized that there were deficiencies in the study and that some information requested by FDA had not been submitted to the agency. The Panel was aware of the state of the art on deep brain stimulation, both the published literature and ongoing studies, and expressed their belief that this treatment has great promise and should be made available to patients with advanced Parkinson’s disease.
The Panel voted unanimously to recommend that FDA should approve the PMA supplement with conditions. The conditions of approval included written instructions for use of the device, extended patient follow-up for 2 to 3 years, and amended indications for the device’s use.
The Panel membership for this meeting consisted of three neurosurgeons, four neurologists, an engineer, a statistician, a consumer representative, an industry representative, and a patient representative.
A closed session to update the panel on neurological device issues was also conducted.
Contact: Janet L. Scudiero, Executive Secretary, at 301-594-1184 ext. 176 or firstname.lastname@example.org.
Transcripts of this meeting may be purchased from Neal R. Gross and Co., 1321 Rhode Island Ave., N.W., Washington, D.C. 20005, 202-234-4433 and the Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, 301-443-1726.