Medtronic Steps Up Trials for Stroke

Medtronic, Inc. (MDT - Analyst Report) recently announced two global clinical trials to study medical device interventions for stroke. These trials are: CRYSTAL AF (Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke) and SISTERS (Spasticity In Stroke – Randomized Study).

CRYSTAL AF trial would assess the incidence of AF (atrial fibrillation) in patients with cryptogenic stroke (stroke of an undetermined cause) or TIA (transient ischemic attack) so that physicians are able to determine the optimal course of treatment for these patients. The company will use Medtronic Reveal XT insertable cardiac monitor (Continuous Monitoring arm) and Medtronic CareLink Network to assess the incidence of AF by monitoring continuous heart rhythm for six months.

The trial would be conducted on approximately 450 cryptogenic stroke or TIA patients without any prior history of AF and it will be conducted at 45 centers across the U.S., Europe and Canada. Patients will be examined in intervals of one, six, and twelve months, and every six months after that. Results are expected in 2012. MDT has already enrolled its first patient for the CRYSTAL AF trial.

SISTERS trial is meant to evaluate the effectiveness of Intrathecal Baclofen (ITB) Therapy in reducing post-stroke spasticity (tightening of the muscles), compared to the best medical therapy available for post-stroke patients. ITB Therapy uses a programmable pump that is surgically implanted in the patient's body and a catheter that delivers medication to relieve severe spasticity. The clinical trial is a randomized, controlled, multi-center study and will involve approximately 88 patients at 20 centers in the U.S. and Europe.

MDT is one of the world's leading medical technology companies, specializing in implantable and interventional therapy devices and products. The company's main competitors include St. Jude Medical Inc. (STJ - Analyst Report) and Boston Scientific Corporation (BSX - Analyst Report).

MDT recently reported its full fiscal year 2009 results with growth in revenue and EPS. Based on this performance, we have recently upgraded the stock to a 'Buy'.