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| |  FDA Clears New, Thinner Medtronic Drug Pumps for Spasticity And Pain MINNEAPOLIS, Sept. 17, 1996 -- Medtronic Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has cleared for commercial marketing two new, thinner models of the Medtronic SynchroMed(R) Implantable Drug Infusion System. The new infusion pumps expand access for children and thinner adults to intrathecal drug therapies that treat two conditions: severe spasticity -- chronic muscle stiffness -- often associated with cerebral palsy, brain injury, multiple sclerosis and spinal cord injury; and pain of malignant (cancer) and non-malignant origins. Implanted just under the skin of the lower abdomen, Medtronic SynchroMed pumps infuse drugs directly into the fluid surrounding the spinal cord through a catheter placed in the intrathecal space (the area surrounding the spinal cord). This direct delivery achieves significant patient benefit with minimal doses of drugs. The new SynchroMed pumps, models 8616-10 and 8617-10, are only .85 of an inch thick, 20 percent thinner than the current models. The thinner pumps are expected to make intrathecal therapies more accessible and more comfortable for smaller patients. Their reservoirs hold 10 milliliters of medication rather than the 18 ml. of the larger models. SynchroMed pumps are the only commercially available implantable pumps that can be programmed from outside the body via telemetry. Physicians can fine-tune the drug dose to meet the needs of each patient by adjusting the rate of flow of medication and time of delivery. A clinician refills the pump by using a needle and syringe to inject the drug through the skin into the drug reservoir. The FDA cleared the SynchroMed system in July 1996 for intrathecal delivery of baclofen for treating severe spasticity due to cerebral palsy and brain injury. The SynchroMed system was cleared for intrathecal delivery of baclofen for severe spasticity due to multiple sclerosis and spinal-cord injury in 1992, and for intrathecal delivery of morphine for treating malignant and non-malignant pain in 1991. Since its initial FDA clearance in 1988 and 1989, more than 30,000 pumps have been implanted worldwide. SynchroMed systems are currently in development as potential delivery devices for medications being developed by biotechnology companies for treating chronic pain, Alzheimer's disease, amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) and Huntington's disease. Medtronic Inc., headquartered in Minneapolis, is the world's leading medical technology company specializing in implantable and invasive therapies. Its Internet address is http://www.medtronic.com.
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