Personal therapy manager will be tested by people receiving intrathecal morphine through implantable infusion system

In collaboration with physicians here at the Center for Pain Management and Rehabilitation, Medtronic, Inc. (NYSE: MDT), embarked last week on the first U.S. clinical trial of a new patient-activated pain-control device that is designed to work with its fully implantable and programmable infusion system.

The multicenter trial seeks to determine the safety and efficacy of the Medtronic SynchroMed® Personal Therapy Manager, which is designed to enable people with chronic pain to manage better their episodes of breakthrough pain –– pain that is above and beyond their normal pain levels. The hand-held device, which is about the size of a TV remote control, can be carried by the patient for use as needed to initiate the delivery of supplemental doses of medication within preset limits determined by the physician.

Pressing the button located on top of the device sends a signal to the implanted pump via telemetry. After the pump software verifies that the lockout interval has elapsed and that the other programmed limits have not been violated, the pump delivers the physician-prescribed dose. In order to communicate with the pump, the device must be held over the site of the pump. Following an attempted activation, the indicator lights on the bottom of the device are used by the patient to confirm that the pump received the instructions and that the dose was delivered.

A 34-year-old woman with low back pain from lumbar facet syndrome on Thursday became the first person in the United States to receive the personal therapy manager. The new device is designed to work with the SynchroMed Infusion System, which the patient received in February 2001 to manage her chronic pain.

Featuring the only implantable and programmable drug pump, the SynchroMed system delivers small, controlled amounts of medication to the intrathecal space, the fluid-filled area in the spinal column through which pain signals travel. Although her pain is well managed most of the time, she experiences episodes of breakthrough pain several times throughout the day. The device is designed to treat those episodes, which she has traditionally tried to manage with oral medication. “It is our hope that patient-activated delivery will help to reduce the number of oral medications taken by people with chronic pain,” said Dr. Morris Scherlis of Tennessee Valley Pain Consultants. “This reduction in medication should result in fewer side effects and, subsequently, a better quality of life for these patients.” A multidisciplinary team from Tennessee Valley Pain Consultants — including Drs. Scherlis, Roddie Gantt and Ron Collins and nurse Carol Weston — are working in partnership with the patient in this study. “We are very excited to be part of this clinical investigation,” said Dr. Gantt, the study’s principal investigator at the Center for Pain Management and Rehabilitation. “This device represents a new era in patient control for pain management.”

Up to 200 patients will participate in a study at 20 U.S. medical centers to determine the safety and efficacy of the device. The study is scheduled to conclude in the fall of 2002.