Our first product, directSTIM™ will establish Aleva as a known entity with neurosurgeons and neurologists, and demonstrate the value of our Technology. This will pave the way for us to simultaneously develop and introduce the spiderSTIM™ DBS Therapeutic System and take full advantage of our technology.
directSTIM™ DBS System
Directional stimulation will target more precisely the area of the brain to be activated. This will improve therapeutic response by reducing risks of side effects.
Surgical implantations of current DBS systems require the neurosurgery staff to spend several hours precisely placing implantable leads in the correct brain location. directSTIM™ uses an array of directional microelectrodes to focus electrical stimulation, potentially decreasing the need for exact positioning. For the neurosurgeon this will “feel” like existing products but eliminate the need for slow and painstaking mechanical calibration, thus surgical times.
Some neurosurgeons may bypass the neurophysiological recording methods used during Parkinson’s surgery, and use directSTIM™ as a combined diagnostic positioning and therapeutic device. Once the neurosurgeon has determined the correct area in the brain for stimulation, directSTIM™ can be left in place as the permanent implant. This has obvious advantages because the surgery is faster and thus safer. Furthermore, directSTIM™ delivers more precise directional stimulation due to its smaller electrodes, hence reducing off-target side effects.
spiderSTIM™ DBS Diagnostic System
Deep Brain Stimulation surgery involves first finding the brain region using electrophysiological recordings. This is done with up to five separate, non-implantable electrodes, and a mechanical apparatus known as the “Ben-Gun”, that painstakingly moves and records from a single electrode tip. This process is slow, inefficient, and often does not give complete information on the best location for the implantable electrode. Worse, once the target area is identified, the diagnostic electrodes are removed entirely and the neurosurgeon then tries to get the permanent DBS stimulation electrode positioned back in the same place.
spiderSTIM™ introduces for the first time the ability to encompass large 3-dimensional areas in a brain target, and record and stimulate the region in order to provide a diagnostic tool. This product will revolutionize the practice of neurosurgery, opening the way to safer surgeries with better clinical outcomes, and the possibility of finding and treating new indications.
In addition to the previously described specifications of the directSTIM™ leads, spiderSTIM™ will also includes:
• Less invasive surgical procedures with easier to measure clinical evaluations
• “Expandable-retractable” electrodes, allowing 3-dimensional access to new areas of brain and enabling new indications
Disclaimer : Aleva’s product are not yet approved for human use.
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