FDA Releases gammaCore®, the First Non-Invasive Vagus Nerve Stimulation Therapy Applied at the Neck for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients
Late Breaking Long Term Clinical Study Results at the International Neuromodulation Society Conference Show Continued Improvement for Stroke Patients and a New 120 Patient Stroke Trial Will Begin Enrollment this Summer
"We saw remarkable improvement in some patients' upper limb function over the course of this trial," said Dr. Dawson. "For many patients, this included important daily activities such as feeding, grooming, driving, and dressing themselves. Some patients were able to resume their higher-level hobbies, such as photography, practicing piano, hosting large family events, and playing golf. Overall, my patients were able to integrate the at- home-therapy component of the program quite easily into their lives."
The Stroke Rehabilitation trial featured the Vivistim® System, which is a neurostimulation based system with a small implanted battery and wires that internally connect to the vagus nerve in the neck. As the patient performs physical therapy exercises, they receive a small burst of neurostimulation to their vagus nerve. This Paired VNS® (Vagus Nerve Stimulation) method is based on decades of neuroscience research and takes advantage of the brain's ability to rewire itself (neuroplasticity). When stimulated, the vagus nerve causes the release of neurochemicals in the brain that encourage neuroplasticity. More information can be found on www.MicroTransponder.com.
In addition to the presentation of the long-term data, Frank McEachern, CEO of MicroTransponder; also spoke at the INS. McEachern announced that MicroTransponder had received IDE approval from the FDA to run a 120-patient pivotal trial. The stroke rehabilitation trial will include 12 U.S. and 3 UK centers and will begin enrolling patients this Summer. "There are currently very few options for chronic stroke survivors and our committed team of physicians, researchers, and engineers hope to deliver a meaningful option that will make a significant difference for these survivors and their families," noted McEachern. "We experienced an outpouring of interest from many academic centers to participate in our clinical trials once we presented our initial stroke rehabilitation data at the International Stroke Conference earlier this year. We are pleased to announce that our 120-patient clinical trial is now approved and includes many prestigious institutions and some of the best stroke and neurostimulation researchers worldwide. Enrollment will begin this Summer and additional clinical trial information can be found by visiting www.vnsstroketrial.com."
About MicroTransponder, Inc.
MicroTransponder Inc. (www.microtransponder.com) is a medical device development company with a strong neuroscience research focus. An experienced team of scientists and engineers has developed neurostimulation technology platforms to treat various forms of neurological diseases, including post stroke motor rehabilitation and tinnitus. MicroTransponder has a sizeable neurostimulation-focused R&D program which is able to quickly translate scientific discoveries into clinical therapies.