A second trial, called SISTERS (Spasticity In Stroke – Randomized Study), is being initiated at centers in Europe and the US to compare the effectiveness of Intrathecal Baclofen (ITB) Therapy to best medical therapy in managing generalized, severe, post-stroke spasticity (tightening of the muscles). This clinical trial is designed to add to the body of clinical evidence for ITB Therapy, which is FDA-approved for the treatment of post-stroke spasticity.

“The clinical trials announced showcase Medtronic’s wide and deep expertise and our commitment to the management of those who have suffered a stroke by reducing its spasticity consequences and maximizing preventive therapy for future strokes,” said Rick Kuntz, M.D., president of the Neuromodulation business and senior vice president at Medtronic. “Stroke is a chronic disease that affects a large population of patients and these two studies seek to provide a higher level of clinical evidence for important medical device interventions that can aid in the diagnosis of stroke as well as the management of intractable spasticity, which is a common outcome of stroke.”