Safety and Efficacy

More Than 30,000 Patients Treated with Activa Therapy

Since 1996, more than 30,000 patients worldwide have used Activa Therapy. The Activa Therapy System has consistently demonstrated a high level of reliability and the therapy is typically well-tolerated.

Safety profile at-a-glance

• Many patients leave the hospital the day after the lead implant procedure.
  
  
• Potential surgical complications are similar to those encountered with other brain surgeries using a stereotactic frame.¹



• Major adverse events reported in Medtronic clinical studies for Activa Parkinson’s Control Therapy include intracranial hemorrhage, device-related infection, paresis/asthenia, and hemiplegia/hemiparesis. Other ongoing, serious adverse events included worsening of motor impairment/Parkinson's symptoms, pain, dysarthria, hypophonia, speech disorder, intermittent continuity, electromagnetic interference, implanted component breakage and skin erosion.¹

Gary was diagnosed with Parkinson’s disease in 1986, at age 49. He began using Activa Parkinson’s Control Therapy in June 1999 to manage his primary symptoms of difficulty walking, freezing episodes, bradykinesia, and dyskinesias. Patient results vary. Not all patients respond in the same way.

---

References

1. Data on file at Medtronic, Inc.
   

©Medtronic, Inc. 2008                                                   • Contact Medtronic • Privacy Statement • Terms of Use • Site Map