An FDA review panel recently voted 11-0 to recommend approval for the cutting edge NeuroPace RNS system—a neuromodulation device for treatment-resistant epilepsy in patients with partial onset seizures.
NeuroPace will hear back from the FDA on final approval in the next few months, but the panel’s endorsement marks a huge step forward for the 30% of epilepsy patients who don’t respond to medication. If the RNS system is approved as expected, it will become the first new epilepsy device in the U.S. since the vagus nerve stimulator (VNS) was approved over 15 years ago.
FDA panel recommends new epilepsy device: First in 15 years
Elizabeth Tiernan and Boer Deng
The rising prevalence of atrial fibrillation in the U.S. has spurred much research around this chronic arrhythmia and its associated risks. Stroke is one of the most challenging events that can occur in relation to AF, and the most commonly used procedures for prevention are pharmacological anticoagulation therapies.
However, of the AF patients at risk for stroke, 14-44% are ineligible for anticoagulation therapy due to contraindications, or would benefit from having their pharmaceutical regime supplemented by other treatments.
For these patients, occlusion, exclusion, or removal of the left atrial appendage (LAA) has been shown to significantly reduce the incidence of stroke. Over the past few years, LAA closure has become a more efficient and effective procedure, due to industry shifts from surgical to percutaneous approaches.
Technologies to watch: Two devices go head-to-head in stroke prevention efforts
Brainsway Ltd. has received FDA approval for the use of their Deep TMS (transcranial magnetic stimulation) system to treat drug-refractory depression, becoming only the second company to win the rights to sell TMS devices in the U.S.
Cutting edge depression treatment faces new competition