The global company will use two separate trials to study the use of medical device interventions in strokes
By Gabe Perna
In the United States, every year - 795,000 people experience a new or recurrent stroke. If these numbers are staggering, keep in mind that half a million people in Western Europe are similarly affected. With this in mind, leading global medical device company, Medtronic, announced two significant clinical trials related to medical device interventions for stroke.
“The clinical trials announced today 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,” stated 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.”
Enrollments in the first global CRYSTAL AF (Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke) trial have taken place. According to a Medtronic press release, it will, "will use the Reveal® XT Insertable Cardiac Monitor (ICM) to assess the incidence of atrial fibrillation (AF) in patients with cryptogenic stroke (stroke of an undetermined cause) or transient ischemic attack (TIA) in order to aid physicians in determining the optimal course of treatment for these patients."
The second trial - SISTERS (Spasticity In Stroke – Randomized Study) will be done in the US and Europe to compare the effectiveness of Intrathecal Baclofen (ITB) Therapy to best medical therapy in managing generalized, severe, post-stroke spasticity (tightening of the muscles). It is designed to to add to the body of clinical evidence for ITB Therapy.
For more: Check out the Medtronic Press Release