second-generation implantable medicine pump has the green light.
Medtronic announced Tuesday morning that it received approval from the Food and Drug Administration for its SynchroMed II programmable pump, which is used to treat chronic pain and the kinds of severe spasticity found in sufferers of cerebal palsy and multiple sclerosis.
The SynchroMed II pump is implanted under the skin near the spinal cord, where it delivers steady doses of medication, either morphine sulfate, for the treatment of pain; or Loioresal Intrathecal, for the treatment of spasticity.
"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 of Medtronic's neurological unit.
The recently-approved unit is designed to be more comfortable for patients and is 30% smaller and 20% lighter than the original version. In addition to a 20 ml version, Medtronic is also making a 40 ml version, effectively doubling the amount of medication in the unit, thereby reducing the number of office visits.
The news comes as the original version of the SynchroMed has run into issues with overseas regulators. Two weeks ago, the UK Medicines and Healthcare products regulatory agency issued an alert on two versions of the SynchroMed pump, saying the units stopped delivering medications because of a software glitch.
No patients were seriously affected by the error, and Medtronic says that its SynchroMed II is not affected by the software issue.