To all: Major FDA Approval Today. See article below.
It was of course reported earlier that approval was near, but I haven't seen any discussion on this thread or elsewhere of the impact of this new product line on Medtronic's earnings. This seems like a real breakthrough in treatment of essential tremor and parkinsons's disease. Given the dramatic results of trial patients, it's difficult to imagine too many victims of these conditions opting for any other treatment. Does anyone have info on the projected earnings for this device and do the consensus earnings estimates for the next year take into account this new product line?
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Medtronic Receives FDA Clearance to Market First Completely New Approach for Tremor in 30 Years August 4, 1997 8:50 AM EDT
More Than a Million People Suffer From Essential Tremor and 500,000 Have Parkinson's Disease
MINNEAPOLIS, Aug. 4 /PRNewswire/ -- Medtronic, Inc. (NYSE: MDT), today announced clearance by the U.S. Food and Drug Administration (FDA) to market the first completely new approach in 30 years for treating people with Essential Tremor and tremor associated with Parkinson's disease -- conditions affecting more than one and a half million Americans.
Tremor -- the disabling, involuntary rhythmic shaking of the limbs or other parts of the body -- is the only symptom of Essential Tremor and one of four major symptoms of Parkinson's disease. The new Medtronic Activa(TM) Tremor Control Therapy uses an implanted device to suppress tremor.
"Before the implant, patients could not raise a glass of water or a spoonful of food to their mouths without spilling or striking themselves in the face," said William Koller, M.D., Ph.D., chairman of the neurology department and professor of pharmacology at University of Kansas Medical Center, Kansas City, Kan. "Within hours, these same patients are sipping tea from a cup and eating peas with a fork, with no signs of their disability. Tremor Control Therapy stops all or nearly all involuntary shaking in most patients almost instantly."
Essential Tremor is the most common neurological movement disorder in this country. The condition affects at least a million Americans, usually age 45 or older. Parkinson's disease is a progressive and degenerative neurological disease that affects approximately 500,000 people in the United States. Tremor worsens from mild to disabling at a variable rate, depending on the individual. Currently, thousands of people throughout Europe, Canada and Australia have the Activa device implanted to control tremor.
"Where tremor takes away a person's ability to perform the most basic tasks, the Activa System suppresses tremor and restores the ability to live life without disabling shaking," said Michael M. Selzer, Jr., vice president and general manager of Medtronic's neurostimulation business. "This therapy is about quality of life, and even more important, it is about the ability to function in life."
The implanted system delivers mild electrical stimulation to block brain signals that cause tremor. The system includes an insulated wire lead that is surgically implanted deep within the brain's communication center, the thalamus. The lead is connected by an extension wire passed under the skin to an implanted pulse generator, similar to an advanced cardiac pacemaker, which is implanted near the collarbone.
Patients control the stimulation by passing a hand-held magnet over the implanted pulse generator to turn it on or off, or to increase or decrease stimulation depending on their tremor suppression needs. To achieve maximum tremor suppression, physicians program the generator to deliver the precise stimulation needed for each individual patient.
"The Activa System is a safe and adaptable therapy for patients whose drug therapy has been ineffective," said Dr. Koller. "For patients whose pharmaceutical options are ineffective, Tremor Control Therapy should be the therapy of choice for two reasons. First, the therapy's programmable feature ensures optimal suppression by meeting customized patient needs. Second, the therapy is reversible should new medical advances be developed."
Patients interested in Activa Tremor Control Therapy should consult their physician or a neurologist specializing in movement disorders to discuss risks and benefits and to assess whether this therapy is appropriate for them. For more information, patients and physicians can call 800-664-5111, extension 1010.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company specializing in implantable and interventional therapies. Its Internet address is medtronic.com. SOURCE Medtronic, Inc. |
