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Medtronic

Executive Summary

Will distribute without charge Ciba-Geigy's Lioresal Injection (baclofen) under a Treatment IND sponsored by the device manufacturer. "The Pink Sheet" reported in its March 19 issue (T&G-10) that Ciba-Geigy would distribute the drug free for the Treatment IND, which will study the effectiveness of baclofen administered through Medtronic's SynchroMed implantable pump as a treatment for spinal spasticity. Physicians treating spinal spasticity patients who have failed on oral antispasmodics may contact Medtronic at 800-328-0810 or 612-572-5000 for information. FDA is requesting the sponsor to call each doctor involved in the SynchroMed/baclofen Treatment IND weekly to ascertain the status of all patients, because of the drug/device combination's limited previous use in patients, the agency noted in a March 20 statement.
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PS017164

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