1. Medtech Insight
  2. >>Business

SISTERS Data Could Lift Medtronic's SynchroMed II From Recall Repercussions

 
• By Reed Miller

The published results of the SISTERS trial demonstrate intrathecal baclofen (ITB) therapy with the recently redesigned SynchroMed II reduces spasticity-related pain and improves quality of life more than conventional medical management with oral antispastic medications in post-stroke patients suffering spasticity. The company hopes these results can boost interest in ITB and the SynchroMed II system while it works to resolve a 2015 consent decree with the FDA related to malfunctions with a previous version of the device.

ITB pump
Medtronic's SynchroMed II Implantable Drug-Pump System • Source: Medtronic PLC

Medtronic PLC hopes the publication of the results from a major randomized trial of its SynchroMed II implanted intrathecal baclofen (ITB) infusion system will draw attention to this therapy for post-stroke spasticity, which is not well-known among patients or their physicians, according to the study's lead investigator.

The results of the 60-patient, randomized, open-label SISTERS trial, including the secondary results, are now published in the journal Stroke

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D