NEW STIMULATION THERAPY TO CONTROL TREMOR RELEASED OUTSIDE THE UNITED STATES BY MEDTRONIC.MINNEAPOLIS--(HealthWire)--Feb. 20, 1995 -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange : MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) today announced commercial release in Europe, Australia and Canada of a new neurostimulation therapy to control the involuntary motion and trembling of the limbs that often afflict and debilitate de·bil·i·tate tr.v. de·bil·i·tat·ed, de·bil·i·tat·ing, de·bil·i·tates To sap the strength or energy of; enervate. [Latin d patients with Parkinson's disease or essential tremor. In the new treatment, an insulated lead bearing four electrodes is inserted through a small hole in the skull and then surgically implanted in the thalamus thalamus (thăl`əməs), mass of nerve cells centrally located in the brain just below the cerebrum and resembling a large egg in size and shape. of the brain. The lead is surgically passed under the skin and connected to a Medtronic Itrel(R) II pulse generator implanted near the clavicle clavicle /clav·i·cle/ (klav´i-k'l) collar bone; a bone, curved like the letter f, that articulates with the sternum and scapula, forming the anterior portion of the shoulder girdle on either side. . Tiny, precisely programmed electrical impulses from the pulse generator are delivered via the lead to the targeted site in the thalamus. The patient uses a magnet held over the skin to turn the stimulation on and off. Tremor suppression is almost immediate when the stimulation is turned on. Parkinson's disease is a common, but complex brain disorder that results in damage to parts of the nervous system involved in control of movement, posture and balance. Essential tremor is a neurologic disorder with no symptoms other than tremor. A Medtronic-sponsored multicenter European study has shown good efficacy in more than 100 patients with Parkinson's disease or essential tremor. Prof. A.L. Benabid, a neurosurgeon in Grenoble, France, is credited with the first systematic studies of thalamic thalamic /tha·lam·ic/ (thah-lam´ik) pertaining to the thalamus. stimulation for tremor. His unique contributions and those of Prof. P. Pollak, a neurologist, include techniques for optimizing target localization Customizing software and documentation for a particular country. It includes the translation of menus and messages into the native spoken language as well as changes in the user interface to accommodate different alphabets and culture. See internationalization and l10n. in the ventral intermediate nucleus of the thalamus and for optimizing electrical frequencies for tremor suppression. Prof. Benabid implanted the first Itrel system for a tremor patient in 1987 and has since implanted systems for more than 100 patients. U.S. clinical evaluations of neurostimulation for tremor have been under way since October of 1993 under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the U.S. Food and Drug Administration. The Itrel II system for tremor is adapted from the Medtronic Itrel II Spinal Cord Stimulation System for control of chronic, intractable pain of the trunk or limbs which is now used by more than 15,000 patients worldwide. Medtronic, Inc., headquartered in Minneapolis, is the world's leading therapeutic medical technology company. CONTACT: Medtronic Inc., Minneapolis Dale Beumer, (Investor Relations), 612/574-3038 or Dick Reid, (Public Relations), 612/574-3052 |
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