To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Intrathecal Baclofen Therapy for Treating Cerebral Palsy Cleared by FDA URL: http://www.pslgroup.com/dg/9946.htm Doctor's Guide June 19, 1996
MINNEAPOLIS, June 19, 1996 -- Medtronic, Inc., (NYSE:MDT) announced release today by the U.S. Food and Drug Administration (FDA) for the company to market Intrathecal Baclofen Therapy, a new treatment for cerebral spasticity. Cerebral spasticity is a chronic, often severe, muscle stiffness that affects approximately 75 percent of the 500,000 Americans with cerebral palsy and many of the 100,000 people who suffer brain injuries each year. The new therapy may be useful in approximately two-thirds of patients with cerebral spasticity associated with a marked increase in muscle stiffness interfering with function and/or care. "Intrathecal Baclofen Therapy adds a new safe and effective therapeutic tool for many patients with spasticity who cannot do the things most of us take for granted -- feeding or dressing ourselves, walking, writing and sometimes, even talking," said president of Medtronic Neurological Business, John A. Meslow. "Medtronic is proud to introduce the first new treatment in 15 years specifically indicated for patients with cerebral spasticity." This non-destructive and reversible therapy provides physicians a new alternative to rhizotomy -- a surgical procedure perfected about 1981 that severs nerves in the spinal canal to allow muscle relaxation. The drug/device combination relieves spasticity by delivering a special formulation of the drug baclofen directly into the spinal fluid, whereas the oral form of the drug is not indicated for this use. Direct delivery makes the difference in achieving significant improvement with minute doses of liquid drug. The pump's reservoir holds 18 milliliters (about 3 1/2 teaspoons) and only needs refilling every one to three months. Intrathecal Baclofen Therapy uses the Medtronic SynchroMed(R) Infusion System that allows flexible dosing by adjusting rate of flow and time of delivery. The system includes a small pump and drug reservoir implanted under the skin of the abdomen. A tiny catheter delivers Lioresal(R) Intrathecal (baclofen injection) into the spinal fluid. While the mechanism of action is not fully understood, baclofen is thought to replace a chemical (GABA), that normally allows muscle relaxation. In clinical studies, Intrathecal Baclofen Therapy maintained long-term reductions in muscle spasticity in both children and adults. "In a majority of patients, spasticity was reduced and ability to move was improved," says lead clinical investigator A. Leland Albright, chief of neurosurgery, Children's Hospital, Pittsburgh. "Other patients experienced improved speech, swallowing and alertness -- often with dramatic differences in ease of care." Children must be at least four years of age and large enough to accommodate the implanted pump. Side-effects of the new therapy include dose-related sleepiness, nausea, headache, muscle weakness and light headedness. Most are temporary and can be alleviated through dose modification. The new therapy is not a cure for cerebral palsy. With the new approval, Medtronic broadens the indications for its SynchroMed(R) Infusion System, already in use worldwide for the delivery of intrathecal baclofen for severe spasticity due to spinal cord injuries or multiple sclerosis, intraspinal morphine for the treatment of chronic pain, and several anticancer agents. Medtronic, Inc., is the world's leading medical technology company, specializing in implantable and invasive therapies. Patients and physicians can call 800/553-9166 for more information about Intrathecal Baclofen Therapy. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.