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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. The results demonstrate that ITB therapy with SynchroMed...

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