Boston Scientific conducts clinical trials of Vercise brain pacemakers in the United States

Release date: 2013-06-26



On June 17, US Eastern Time, Boston Scientific announced a clinical trial program called INTREPID in the United States. INTREPID is a prospective, multicenter, double-blind, randomized, and controlled study designed to assess the safety of Parkinson's patients with improved motor function after applying the company's Vercise deep brain stimulation system (DBS). Effectiveness, as well as the overall quality of life of the patient.
Vercise integrates multiple independent current control components to selectively stimulate the target area of ​​the brain. According to Boston Scientific's press release, Vercise is the only system that can perform fine current adjustments based on the condition.
According to previous studies in the European Union, 40% of patients were successfully implanted with Vercise; 6 months of follow-up, approximately 60% of motor function was significantly improved; all patients were well tolerated.
In the United States, Vercise is currently only available for clinical research, and the INTREPID research program is intended for FDA approval. If it goes well, it is expected to be approved by the FDA two years later.
Boston Scientific also developed the Guide DBS guidance system, which provides 3D images of the brain and simulates treatments. Guide DBS and Vercise can be used together, and it is unclear whether the two will be combined for clinical trials.



Source: China Medical Technology Network

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