The US FDA has approved the second implantable medical device for the treatment of symptoms of Parkinson’s disease. The device, Brio Neurostimulation System, provides relief from essential tremor, shaking and difficulty in walking and maintaining balance, that severely affect the quality of life of patients with Parkinson’s. There are several significant regulatory observations that can be made for this device’s approval. This is the first such device approved in 18 years and involved vigorous clinical trials to support the market approval. Two large clinical trials in 263 patients with advanced symptoms of Parkinson’s were operated to install the device and patients took both their regular drug treatments along with the device. The device was approved despite some severe side effects including intracranial bleeding since there are no treatment options to the target patients and the benefit outweighed the risk. The device is powered by a battery that met a more robust recent FDA requirement for batteries.
This electronic device can be implanted under the skin of the upper chest and is connected with wires to the electrodes which can be planted deeper into the specific brain locations, from where it sends electronic pulses. The Brio Neurostimulation System is developed for the cases, where medication becomes partially ineffective and patients doesn’t get adequate relief from its symptoms. It’s one of the best ways to manage the symptoms of Parkinson’s, given the untreatable nature of the disease. Review of the clinical trial design and FDA approval package of this device promises to be a great learning experience for all device clinical trial sponsors.
Source: http://goo.gl/ZG6DRT
