Medtronic Announces FDA Approval of Smaller Implantable Drug Pump for Chronic Pain, Severe Spasticity

Published: June 21, 2004
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New programmable pump features greater accuracy, larger reservoirs and longer refill intervals, making treatments more convenient and easier to manage

Medtronic, Inc. (NYSE:MDT), today announced that it has received approval from the U.S. Food and Drug Administration for its SynchroMed(R) II Programmable Pump for the treatment of chronic pain and the management of severe Spasticity – the tight, stiff muscles commonly associated with cerebral palsy, Multiple Sclerosis, stroke, brain injury and spinal cord injury.

The SynchroMed II pump offers several benefits to patients and physicians. The new 20 ml version is 30 percent smaller and 20 percent lighter than the previous model, and the new pump’s smaller size and contoured shape is designed to enhance patient comfort. The new pump also comes in a 40 ml version, which can extend refill intervals by up to two times the current intervals, thereby reducing the number of office visits patients must make to have their pumps refilled. In addition, physicians can adjust the SynchroMed II pump to meet individual patient needs.

For the treatment of chronic, intractable pain or severe spasticity, the new pump delivers specially formulated medications – preservative-free morphine sulfate for chronic pain; Lioresal(R) Intrathecal (baclofen injection) for severe spasticity – directly to the intrathecal space, the fluid-filled area surrounding the spinal cord. This site-specific delivery targets the medication’s site of action in the spinal cord, thereby minimizing the dose requirements and side effects compared to oral administration of the same drugs. Both drugs have proven to be stable for six months in this new pump.

“With the convergence of pharmacology and electrical, mechanical and software engineering, the SynchroMed II programmable pump is an incredible advance in medical technology,” said Jon Tremmel, president, Medtronic Neurological. “The marriage of these technologies creates a new drug delivery platform that will improve patient care today while enabling the development of new therapeutic solutions for neurologic diseases and chronic pain in the future.”

The SynchroMed II Programmable Pump also has received CE Mark, the European regulatory approval for medical devices, and is commercially available in Europe. In the U.S., the new pump currently is available in limited markets, with full commercial availability expected in June.

Medtronic implantable infusion systems have helped tens of thousands of patients worldwide with cancer pain, nonmalignant pain and severe spasticity.

Because the drug pump is surgically placed, complications such as infections are possible; post-implant interruptions could occur, causing a reduction in or loss of symptom relief from the medication. Drug-related side effects also can occur. Close attention by patients to their physicians’ instructions is required.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease.

Any statements made about the company’s anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company’s Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.

Lioresal(R) is a registered trademark of Novartis Pharmaceuticals Corporation.

ITB therapy drug side effects are usually temporary and manageable by adjusting the dose. The most common side effects include loose muscles, drowsiness, nausea/vomiting, headache and dizziness. Close attention to your doctor’s instructions is required since abrupt cessation of Intrathecal Baclofen can result in high fever, altered mental status, returned spasticity, and muscle rigidity, and in rare cases has been fatal.

© Business Wire 2004