ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Scientifically-designed fasting diet lowers risks for major diseases

More evidence for calorie restriction’s longevity effect

Supplementation with vitamin D associated with improved testosterone, erectile function among middle...

A Little Zinc Goes a Long Way

Vitamin D deficiency increases risk of chronic headache

Get the Most From Your Green Tea

VIDEO: The Best Brain Foods That Help Increase Your Memory!

Acupuncture boosts effectiveness of standard medical care for chronic pain, depression

Iron (And More) For Lasting, Natural Energy

Metabolic syndrome increases the need for vitamin E

 
Print Page
Email Article

FDA Approves Expanded Use of Brain Implant for Parkinson's Disease

  [ 55 votes ]   [ Discuss This Article ]
www.ProHealth.com • February 12, 2002




FDA today approved an expanded use of a brain implant to help control some symptoms of advanced Parkinson's disease.

The device, a deep brain stimulator, made by Medtronic, Inc., of Minneapolis, Minn., was initially approved by FDA in 1997 for use in one side of the brain to help control tremors on one side of the body.

Today, after review of additional studies conducted by the manufacturer, the agency approved the device, called the Activa Parkinson's Control System, for use in both sides of the brain to help reduce some of the other symptoms of advanced Parkinson's that cannot be adequately controlled with medication.

An estimated 1.5 million Americans have Parkinson's disease, which results in tremors, rigidity, postural instability, slowness and difficulty moving and, in some people, intellectual deterioration.

The Activa system consists of electrodes that are implanted into the brain and connected by leads (wires) under the skin to a pulse generator implanted in the abdomen or chest. The pulse generator sends a constant stream of tiny electrical pulses to the brain, blocking tremors. When the device is implanted in both sides of the brain, two separate systems are used.

To turn the stimulator on and off, the patient holds a magnet over the pulse generator. The generator must be replaced every three to five years, the life of the battery.

FDA based approval of the device on a clinical study conducted by Medtronic of the system's safety and effectiveness when implanted in both sides of the brain and on the recommendation of the Neurological Devices Panel of FDA's Medical Devices Advisory Committee.

Some 160 patients with advanced Parkinson's disease were enrolled at 18 medical centers in the United States, Canada, Australia and Europe. The device was implanted bilaterally in 134 patients. The implant procedures were done simultaneously or in stages. The patients were followed for approximately one year.

During the study, patients were evaluated for a variety of Parkinson's symptoms using a test for total motor skills, including hand movement, leg agility, facial expression, rigidity, tremor and speech. They were tested with the Activa system turned on, both with and without medication. Total motor skills improved in nearly half the patients taking medication and approximately 90 percent of the patients not taking medication.

In addition, diary data from a subset of 64 patients in the study showed that the Activa device increased good motor function and relief from Parkinson's symptoms by an average of six hours a day. And it decreased by an average of three hours a day the amount of time the patients experienced abnormal, involuntary movements such as a waving of arms.

Although some patients in the study benefited significantly from the Activa system, the study also showed that individual results varied considerably and specific benefit for an individual cannot be predicted.

Nearly all of the 160 patients enrolled in the study experienced one or more adverse events. During the entire study, 7.5 percent had bleeding into the brain; 11 percent had device-related infection; 10 percent had weakness (paresis/asthenia), and 8 percent had paralysis or weakness on one side of the body (hemiplegia/hemiparesis).

Some 37 percent of the adverse events, such as breakage of the lead, pain and infection, were related to the Activa system. Six percent of the device-related adverse events were serious and ongoing, including a worsening of motor impairment and other Parkinson's symptoms.

Medtronic has agreed to conduct a three-year, post- approval study of the system to assess its long-term clinical results.

T02-03 Sharon Snider: 301-827-6242
January 14, 2002 Consumer Inquiries: 888-INFO-FDA



Post a Comment

Featured Products From the ProHealth Store
Ultra EPA  - Fish Oil Mitochondria Ignite™ with NT Factor® Ultra ATP+, Double Strength

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Secret Nutrient for Radiant Skin Secret Nutrient for Radiant Skin
Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask
Block Acid Reflux to Prevent Esophageal Problems! Block Acid Reflux to Prevent Esophageal Problems!
Vitamin K-2 – A Key Player in Cardiovascular and Bone Health Vitamin K-2 – A Key Player in Cardiovascular and Bone Health
How I Found My Long-Lost Energy How I Found My Long-Lost Energy

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map