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Sent: Monday, January 14, 2002 8:47 PM Subject: [Activa] FDA approval Earlier today, Medtronic was granted approval for Activa to be used for Parkinson's. The following news story gives details on the bilateral approval. * * * * * * U.S. FDA approves Medtronic device for Parkinson's By Lisa Richwine WASHINGTON, Jan 14 (Reuters) - U.S. regulators said Monday they approved an implanted device made by Medtronic Inc. MDT.N> for treating symptoms of advanced Parkinson's disease by sending electrical pulses to areas deep inside the brain. Medtronic said its Activa Parkinson's Control Therapy is intended for the around 100,000 patients in advanced stages of the disease who find that the drug levodopa does not adequately control their symptoms. Activa is designed to complement drug treatment, the Minneapolis-based company said in a statement. The device, which the U.S. Food and Drug Administration first approved in 1997 for treating essential tremor and Parkinsonian tremor, has the potential to generate hundreds of millions of dollars per year for Medtronic, Banc of America Securities analyst Kurt Kruger said. Medtronic, the world's largest medical device company which is best known for its heart pacemakers and other cardiac devices, dubs Activa a "brain pacemaker" and a major advance against Parkinson's. For treating essential tremor and Parkinsonian tremor, the device is implanted in one side of the brain. The FDA clearance announced Monday expands the approved indications in the United States for use on both sides of the brain. Activa "was getting started and was on a good growth trajectory. This (approval) certainly will help," Kruger said. The product consists of electrodes implanted into the brain and connected by wires under the skin to a generator implanted in the abdomen or chest. The generator sends tiny electrical pulses to areas deep inside the brain that are hyperactive in patients with Parkinson's disease. A Medtronic study showed the treatment safely improved patients' movement control and mobility, Medtronic said. Medtronic also said the therapy can help reduce the duration of dyskinesia, an uncontrollable shaking and flailing. Patients can adjust treatment by holding a magnet over the generator to turn the device on or off. Parkinson's disease develops when brain cells that produce an important message-carrying chemical called dopamine die off. Patients develop tremors and eventually lose control of movement. The disease is treatable with drugs, but the effects wear off, and there is no cure for the fatal disease. Some patients in Medtronic's study "benefited significantly" from the Activa system, the FDA said in a statement. But the study "also showed that individual results varied considerably, and specific benefit for an individual cannot be predicted," the agency said. Medtronic has agreed to conduct a three-year study to evaluate long-term results, the FDA said. Nearly all of the 160 patients in Medtronic's study experienced one or more adverse events, the FDA said. Some 37 percent of the adverse events, such as wire breakage, pain and infection, were device-related. Six percent of the device-related events were serious and ongoing, including a worsening of motor impairment and other Parkinson's symptoms, the agency said. An estimated 1.5 million Americans have Parkinson's disease, according to the FDA. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn