California neurostimulation devices maker NeuroPace crept 1 step closer to an FDA win for its epilepsy implant with near-unanimous approval from the FDA’s Neurological Devices Advisory Panel.
The expert panelists today voted unanimously that the RNS implantable neurostimulator demonstrated safety in clinical trials, 12 of 13 voted that the device demonstrated reasonable effectiveness, and 11 of 13 voted that the benefits outweigh the risks. There were no negative votes from the panel, with 1 member abstaining on the question of effectiveness and 2 abstaining from the question of the risk-benefit ratio.
NeuroPace hopes to win FDA approval for the 1st-of-its-kind RNS system is as an adjunctive therapy to reduce the "frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than 2 foci that are refractory to 2 or more anti-epileptic medications," according to the company.
The RNS device is surgically implanted in the cranium where it senses and records electrocorticographic (ECoG) patterns from intra-cranial electrodes. The device delivers short trains of electrical energy to the brain in order to interrupt dangerous activity indicative of a seizure.
The RNS implant’s detection and stimulation parameters can be tuned to optimize seizure control against stimulation-related side effects, and the device can be programmed using a wide range of different detection algorithms and responsive stimulation outputs, the FDA noted.
The device continuously records brain activity and the data captured immediately before and after a storage trigger event (such as abnormal electrical activity) is retained for review by a physician and periodically uploaded to an online database. Physicians can use the data to look for patterns in detections, reported seizures and the effects of stimulation.
The FDA originally rejected NeuroPace’s 2010 PMA application on the grounds that the company failed to provide 12-month follow-up on data on all study subjects, which the agency had requested in the RNS device’s investigational device exemption.
The FDA issued a "Not Filing" decision on July 26, 2010, and NeuroPace filed a PMA for RNS on November 9, 2010, after submitting an amendment with 12-month data on all subjects.
The FDA responded with a "Major Deficiency" letter on on June 14, 2011, seeking clarification on clinical and statistical issues. NeuroPace provided additional information and FDA today asked the Neurological Devices Panel whether the data provided was enough to approve RNS based on a reasonable assurance of the safety and effectiveness of the RNS system for its intended use.
The RNS implant may have to compete with other treatment alternatives with known benefits and lower risk, the FDA noted. Existing options include drug therapy and Vagus Nerve Stimulation, another neurostimulation implant therapy that sends small pulses of electrical energy to the brain via the vagus nerve in the neck.
