A summary of cutting-edge technology that includes the world’s smallest fully implantable spinal cord neurostimulator for the treatment of chronic pain.
Neuro INSIGHTEC’s Exablate Neuro received FDA approval for use along with GE Healthcare’s 1.5 Tesla MRI. Exablate Neuro uses MRI imaging to target the ventral intermediate (VIM) thalamic nucleus and deliver focused ultrasound to ablate the tissue without the need for craniotomy, ionizing radiation, or implants. The system has potential for treating neurological disorders and cancer by non-invasively breaching the blood brain barrier to deliver drugs: treats essential tremor in adults with insufficient response to medication; previously approved to run alongside GE’s 3.0T MRI, found in few hospitals; the new approval means many more hospitals with 1.5 T MRI machines can use Exablate Neuro for MR-guided focused ultrasound procedures. Study is underway to use the same system to open the blood brain barrier for treating AD. https://www.insightec.com/us.
In November 2017, Stryker’s Neuroform Atlas stent received FDA approval via humanitarian device exemption to treat brain aneurysms. It is intended for use with neurovascular embolic coils to treat wide neck, intracranial, and saccular aneurysms. Because it has the lowest profile delivery system currently available in the US, it is able to reach difficult locations within the brain, which may allow patients otherwise considered too risky to be eligible for stenting therapy. https://www.stryker.com/us/en/index.html.
Designed to deliver drugs directly into the brains of patients with epilepsy the Prometra II pump was jointly developed by Iowonix (Mt. Olive, NJ), and Cerebral Therapeutics (Aurora, CO). The device is externally programmable by a physician and refillable with a syringe. The battery lifetime is about 10 years. The world’s first trial of patients with medically refractory epilepsy implanted with the device is currently being conducted at St. Vincent’s Hospital in Melbourne, Australia. The trail is testing valproate delivered directly into the brain vie Prometra II. http://www.flowonix.com/healthcare-provider/products/prometra-pump.
The Intellis Implantable Neurostimulation system, made by Medtronic, received FDA approval in September 2017. It is the world’s smallest fully implantable spinal cord neurostimulator for the treatment of chronic pain. By delivering high- and low-dose therapy and its ability to track patient activity to help target pain the device can potentially have an impact on the opioid epidemic. The system connects wirelessly to the Samsung Galaxy S2 Tablet, which can be used to adjust settings, set parameters, and upgrade the system. Moreover, it is safe to wear inside MRIs, provided certain precautions are taken. http://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems/intellis-platform.html.
The SenTiva Neurostimulator for Epilepsy made by LivaNova was approved by the FDA in October 2017 for treating epilepsy in patients as young as age 4. It includes the SenTIva implantable neurostimulator and VNS Therapy Programming system. The device monitors brain activity and delivers therapy when a seizure is imminent. If during therapy the initial attempts fail it monitors and increases stimulation as needed. Wirelessly programmable using an app on a computer tablet it allows physicians to guide programming to deliver treatment when needed, schedule programming for multiple therapeutic steps, and perform day and night programming. https://us.livanova.cyberonics.com.