Medicare coverage for Activa Therapy

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Agency's decision expands access to Medtronic's Activa Therapy to thousands more Americans

MINNEAPOLIS -- February 6, 2003 - In a move that will expand access nationwide to a breakthrough treatment for advanced stages of Parkinson's disease and Essential Tremor, the federal Centers for Medicare and Medicaid Services (CMS) today established a national Medicare coverage policy for Activa Therapy, or brain stimulation, from Medtronic, Inc. When the new policy is fully implemented, every Medicare beneficiary who needs or stands to benefit from brain stimulation will be covered.

Activa Therapy uses Medtronic's "brain pacemaker" technology to control the disabling symptoms of the two most common neurological movement disorders. Most private insurers already cover the treatment, and more are expected to follow suit in the wake of CMS's decision to provide national Medicare coverage.

Combined, Parkinson's disease and Essential Tremor affect 2.5 million Americans. CMS (formerly the Health Care Financing Administration, or HCFA) is the government agency that administers the healthcare programs covering an estimated 75 million Americans. Activa Therapy has become the treatment of choice for Parkinson's disease and Essential Tremor when medication alone fails to provide adequate benefit or consistently causes intolerable side effects, according to Dr. Roy Bakay, director of functional and restorative neurosurgery at the Chicago Institute of Neurosurgery and Neuroresearch (CINN), and professor and vice chairman of neurological surgery at Rush-Presbyterian-St. Luke's Medical Center in Chicago.

A pioneer in the treatment of neurological movement disorders and an advocate of expanding coverage for proven applications of brain stimulation, Dr. Bakay summarized the significance of the CMS decision: "No matter where they live, people on Medicare with Parkinson's or tremor will have equal access to Activa Therapy. No longer will some patients be denied this emerging standard of care because of coverage issues." "For now," he said, "in the absence of a cure, brain stimulation represents the best option for many people whose lives have become severely compromised by these devastating disorders. Importantly, it keeps patients' options open for the future while providing symptom relief now." Added Scott Ward, president of Medtronic's Neurological and Diabetes business: "The agency's decision marks another milestone in the development of this proven treatment for people in advanced stages of Parkinson's or Essential Tremor. With national coverage for brain stimulation, Medicare beneficiaries everywhere nationwide will have clear access to Activa Therapy."

Activa Therapy works by stimulating deep brain structures that influence motor control -- effectively blocking abnormal brain signals that cause disabling symptoms. The treatment can be adjusted noninvasively by a clinician with a special programmer, and its effects can be reversed by turning off the stimulation or removing the device. Similar in size to a cardiac pacemaker and implanted near the collarbone, a medical device generically called a neurostimulator, or "brain pacemaker," generates precisely controlled electrical pulses that are delivered to the brain through electrodes attached to a thin wire. Studies show that Activa Therapy can dramatically improve mobility and movement control in properly selected patients. According to an article published in the Sept. 27, 2001 issue of the New England Journal of Medicine, brain stimulation "is associated with significant improvement in motor function in patients with Parkinson's disease whose condition cannot be improved with medical therapy." The article presents data collected in Medtronic's global multicenter clinical trials, which led to the U.S. Food and Drug Adminstration's approval for brain stimulation as a treatment for Parkinson's in January.

Brain stimulation has been studied for more than two decades. Data supporting its safety and efficacy have been published in dozens of peer-reviewed medical journals and presented at hundreds of scientific meetings for neurologists, neurosurgeons and neuroscientists. Designating brain stimulation "substantially more effective" than the alternatives, an expert panel charged by CMS to review the data in June declared unanimously in an official motion: "The new intervention improves health outcomes by a substantial margin, as compared to established services or medical items." In the trials sponsored by Medtronic, Activa Therapy for advanced Parkinson's disease increased "on" time -- periods of good motor function and symptom relief -- by an average of more than six hours per day at 12 months in patients whose data were verified against medical records. This dramatic improvement occurred while dyskinesia -- the uncontrollable, involuntary movements that often result from anti-Parkinsonian medications -- decreased significantly.

The total cost of Activa Therapy ranges on average from $25,000 to $30,000 per side for the device and the associated physician and hospital fees, which vary. Most private payors, and imminently Medicare, cover the vast majority of the cost.

Parkinson's disease and Essential Tremor are the two most common neurological movement disorders. Parkinson's disease afflicts approximately 1 million Americans; Essential Tremor, about 1.5 million. Tremor is a common symptom of both conditions, but Parkinson's also causes rigidity, slowness of movement and poor balance. Both can lead to significant disability and loss of independence.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Activa Therapy is available online at www.newhopeforparkinsons.com.

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