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