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First Patient Enrolled in Trial to Assess Pain Control and Oral Opioid Elimination

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Streetinsider reports Medtronic plc (NYSE: MDT) today announced the first patient enrolled in the Embrace TDD (targeted drug delivery) clinical study that will evaluate the use of the SynchroMed(TM) II intrathecal drug delivery system (“Medtronic pain pump”) as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain. The Medtronic pain pump provides effective pain relief at a fraction of the oral dose with fewer side effects and may help reduce or eliminate the use of oral opioids.1-7 The Embrace TDD study will follow patients who wean completely from all oral opioids and have a successful intrathecal drug trial. The first patient was enrolled by John A. Hatheway, M.D., in Spokane, Washington.

The Embrace TDD clinical trial is a post-market study to evaluate Intrathecal morphine as an alternative to systemic opioids for chronic pain. It is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain. The leading medical device manufacturer expects to enroll 100 patients over a three- year period.

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Maegan J. Johnson

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