By William Langbein
NEW YORK (Reuters Health) – Medtronic, Inc. has launched a 200-patient clinical trial to test a new patient-activated device designed to work with the company’s SynchroMed pain control system.
The SynchroMed system is implanted under the skin in the abdomen and delivers small, controlled amounts of pain medication (frequently morphine) to the intrathecal space, a fluid-filled area in the spinal column through which pain signals travel.
The programmable SynchroMed system is prescribed after oral drugs and physical therapy have proven to be ineffective. Doctors typically adjust the amount of programmed medication delivered to the intrathecal space in monthly or quarterly intervals.
Cancer patients and patients in which back surgery was unsuccessful are two types of patients that would potentially use the SynchroMed system.
In the new trial, Medtronic plans to test a hand-held device that will allow patients to initiate delivery of supplemental doses of medication within preset limits determined by the physician. Medtronic spokesman Joe McGrath said that patients could use the device, about the size of a television remote controller, to address “spikes in pain” that can occur in the lower back or other areas of the body.
While physicians can generally stabilize the amount of chronic pain through programming adjustments, they cannot compensate for known surges of breakthrough pain, said McGrath. The SynchroMed personal therapy manager can empower patients–within dosage limits–to take more control over their episodes of pain and health, he added.
Most patients now try to treat breakthrough pain through additional oral medication.
The device works when the patient presses a button on top of the device that 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 supplemental physician-prescribed dose.
A 34-year-old woman with low back pain from lumbar facet syndrome was the first US patient to receive the personal therapy manager from investigators at the Tennessee Valley Pain Consultants. She received the SynchroMed Infusion System to manage her chronic pain in February.
Medtronic plans to conduct the personal therapy manager trial at 20 sites in the US; four already have been selected. The company expects to complete the trial in one year.
After the trial is completed, McGrath said that Medtronic would file the safety data necessary for a supplemental 510(k) application with the US Food and Drug Administration in the third or fourth quarter of 2002.
Medtronic has implanted about 50,000 SynchroMed systems, according to the spokesman. A portion of the estimated 300,000 patients who suffer from chronic neuropathic back pain may be candidates for the SynchroMed system, as well as all of the 200,000 cancer patients who experience chronic pain.
In Wednesday trade on the New York Stock Exchange, shares of Medtronic fell 0.46 to close at 44.95.