Synchromed(R) El Expands Patient Access To Innovative Neurological Therapies
Wednesday May 5, 12:33 pm Eastern Time
Company Press Release
SOURCE: Medtronic, Inc.
MINNEAPOLIS, May 5 /PRNewswire/ -- In an action that will benefit patients with chronic pain or severe muscle spasticity, Medtronic, Inc., today announced that it has received U.S. Food and Drug Administration (FDA) approval to market the Medtronic SynchroMed® EL infusion system. This implantable drug infusion system delivers medication directly into the fluid surrounding the spinal cord.
( Photo: http://www.newscom.com/cgi-bin/prnh/19990505/MNW020 )
The SynchroMed EL (Extended Life) system builds upon the success of the Medtronic SynchroMed® drug infusion system, the world's only implantable infusion system programmable from outside the body. First released in 1988, the SynchroMed system is used today in the delivery of morphine to treat cancer pain and nonmalignant pain, as well as in the delivery of intrathecal baclofen to treat severe spasticity.
This implantable drug delivery system has helped nearly 50,000 patients with cancer pain, nonmalignant pain, or spasticity due to cerebral palsy, brain injury, multiple sclerosis, spinal cord injury and stroke. Like the original SynchroMed system, the SynchroMed EL is surgically placed beneath the skin of the abdomen and delivers drugs via a catheter directly into the fluid surrounding the spinal cord. Because medications are delivered to the site where they can be the most effective, small, concentrated dosages may significantly control chronic pain or severe spasticity. Smaller doses also can mean fewer negative side effects.
With SynchroMed EL, advancements in technology will add about three years of battery life before replacement, depending on dosage. It will also extend the average time between replacement surgeries from the four-year life of the SynchroMed to seven years in the SynchroMed EL when programmed at average flow rates. In addition, the system can precisely deliver very low drug dosages (as small as 48 microliters, or about one-twentieth of a drop per day).
"The SynchroMed EL system demonstrates Medtronic's continuing partnership with physicians to develop products that address patient needs," said Scott Ward, vice president and general manager of Medtronic's Drug Delivery Business. "The extended battery life makes our SynchroMed system even more cost-effective for the duration of a patient's treatment, and the lower flow rates allow for a wider range of drugs and concentrations to be clinically investigated. This will help in developing new answers to unmet medical needs."
In future clinical studies by biotechnology companies, the system will
be used to deliver investigational medications directly to the brain for
treating epilepsy and malignant brain tumors. (The safety and efficacy
of these investigational medications have not been
Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life and alleviate pain. Its Internet address is http://www.medtronic.com
Any statements made about the company's anticipated financial results
and regulatory approvals are forward-looking statement subject to risks
and uncertainties such as those described in the company's Annual Report
on Form 10K for the year ended April 30, 1998. Actual results may differ
materially from anticipated results.
SOURCE: Medtronic, Inc.