FDA Approval of "Brain Pacemaker" for Parkinson's --Part 1, by Medtronic Newsroom
'Brain Pacemaker' Receives FDA Approval for Parkinson's Disease
MINNEAPOLIS --Jan. 14, 2002--
When drugs alone become inadequate, Medtronic's Activa® Therapy can improve movement control and mobility while preserving options for future treatments.
The estimated one million Americans with Parkinson?s disease received good news today when Medtronic, Inc. (NYSE: MDT), announced the U.S. Food and Drug Administration?s approval of Activa® Parkinson's Control Therapy.
The revolutionary new treatment uses Medtronic's "brain pacemaker" technology to relieve the debilitating slowness, stiffness and shaking that characterize this progressive and degenerative movement disorder, which gradually robs patients of their independence. Activa Therapy can also reduce the duration of dyskinesia, the abnormal, involuntary movements that are a common side effect of medications for Parkinson's disease.
The therapy, which delivers carefully controlled pulses of electrical stimulation to precisely targeted areas of the brain using an implanted medical device akin to a cardiac pacemaker, is the most significant advance in the treatment of Parkinson's in more than 30 years. It is intended as an adjunctive, or complementary, treatment for the approximately 100,000 patients in advanced stages of the disease who still respond to the drug levodopa but whose symptoms are not adequately controlled by medications.
"Activa Therapy is a major breakthrough in the treatment of Parkinson's disease, because up until this point, patients relied on medications such as levodopa that over time may not provide control of symptoms and that may, in fact, produce significant side effects," said neurologist William J. Marks, Jr., M.D., assistant professor of neurology at the University of California, San Francisco, and medical director of the Center for Parkinson's Disease & Movement Disorders at the San Francisco Veterans Affairs Medical Center. "Now we have an effective new approach to treating the disabling symptoms of this disease."
"Because Activa Therapy is adjustable, we can provide significant symptom relief while minimizing side effects," Dr. Marks added. "And the therapy is reversible, which means patients will be able to pursue new treatments that may be developed in the years ahead."
Based on a study sponsored by Medtronic and conducted at 18 centers in North America, Europe and Australia, the data submitted to the FDA showed that Activa Parkinson's Control Therapy safely and effectively improved movement control and mobility in patients with advanced stages of the disease, when drugs alone proved inadequate.
Of the 117 patients whose data were verified against medical records, 73 received stimulation of the subthalamic nucleus (STN) and 44 received stimulation of the globus pallidus pars interna (GPi). (The STN and GPi are deep brain structures that become hyperactive in Parkinson?s disease; there is one of each structure on both sides of the brain.) With Activa Parkinson's Control Therapy, symptoms improved for 56 of the 117 patients while on medication and for 102 of the 117 patients while off medication.
In addition, "on" time -- periods of good motor function and relief from symptoms -- improved in a subset of 64 patients with verifiable diaries, increasing by an average of 6.7 hours in the GPi group (24 patients) and 6.1 hours in the STN group (40 patients). "On" time with dyskinesia improved as well, decreasing by an average of 4.2 hours in the GPi group and 2.8 hours in the STN group.
Some results of the same study were reported in the Sept. 27 issue of the New England Journal of Medicine.
The cause of Parkinson's is unknown, but the symptoms stem from the degeneration of neurons (brain cells) that produce dopamine. Dopamine is a neurotransmitter that enables communication among the brain cells involved in motor control. Activa Therapy's electrical stimulation acts on these malfunctioning circuits in the brain.
In the late stages of the disease, when symptoms are at their worst, patients often experience debilitating dyskinesia as a side effect of Parkinson's medication. The uncontrollable shaking and flailing that rack their bodies can lead to avoidance of public situations and self-isolation. Eventually, the combination of symptoms and side effects can cause patients to become totally dependent on others for their care.
"You give up a lot more than you'd ever imagine," said Sherry Swinford, 57, a Parkinson's sufferer from Pilot Hill, Calif., who began receiving Activa Therapy in October 1999. "I couldn't cut my own steak in a restaurant. My right leg would shake. I'd shuffle, and people would look at me as though I'd been drinking. The comments were terrible. I didn't want to be seen in public."
"Before Sherry began Activa Therapy, we were cut off from doing a lot of things with our friends and family," said Mack Swinford, Sherry's husband. "Now we're able to get out and enjoy ourselves a lot more."
The approval of Activa Parkinson's Control Therapy expands the indications for Medtronic's "brain pacemaker" in the United States. In July 1997, the FDA approved Activa Tremor Control Therapy for the treatment of Essential Tremor and Parkinsonian tremor.
In Europe, Canada and Australia, Activa Parkinson's Control Therapy has been available since April 1998 and Activa Tremor Control Therapy since February 1995. To date, about 15,000 people worldwide have been implanted with "brain pacemakers" to treat their disease.
"Medtronic has the privilege of collaborating with the world's leading physicians and clinical researchers in developing innovative approaches to treating neurological disorders," said Scott Ward, president of Medtronic Neurological and Diabetes. "Activa Parkinson's Control Therapy is Medtronic's latest achievement in restorative neuroscience, and we look forward to providing other innovative therapies for chronic diseases of the central nervous system."
Brain stimulation also shows promise for the treatment of other neurological disorders. It represents one aspect of Medtronic's focus on advancing the study and practice of restorative neuroscience, an emerging area of medicine that relies on neurosurgery, neurology, neurophysiology and biomedical engineering to restore the function of the central nervous system.
Medtronic, Inc. www.medtronic.com, headquartered in Minneapolis, is the world?s leading medical technology company, providing lifelong solutions for people with chronic disease. People who want more information about Activa Therapy can visit www.brainpacemaker.com or call 1-800-664-5111, ext. 1100.
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 27, 2001. Actual results may differ materially from anticipated results.
Editor's Note: Additional information and graphics related to Activa Parkinson's Control Therapy are available at www.activapresspage.com and through Medtronic's online newsroom: www.medtronic.com/newsroom.
Rachael Scherer, Medtronic Investor Relations. 763-505-2694
Kevin Lee, Medtronic Investor Relations, 763-505-2695
Joe McGrath, Medtronic Public Relations, 763-505-2634
James Larkin, Ketchum, 415-984-2295
SOURCE: The Medtronic Newsroom
Part 2, from The Boston Globe