Is NeuroPace fda approved?

Table of Contents

today announced that the U.S. Food and Drug Administration has granted premarket approval for the NeuroPace® RNS® System, a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs.

What is a neurostimulation device RNS also referred to as NeuroPace?

NeuroPace is a medical device that observes and addresses brain activity causing seizures. Much like a heart pacemaker, the NeuroPace RNS device is implanted in the body and then automatically detects unusual brain patterns and sends electrical pulses to interrupt seizure activity.

How long does NeuroPace last?

Your Neurostimulator is powered by a battery and will need to be replaced when battery power is low. The Neurostimulator should last 2 to 3.5 years with typical use.

How many people have NeuroPace?

WHAT’S THE IMPACT? NeuroPace estimates that there are approximately 575,000 adult drug-resistant focal epilepsy patients across the U.S., which it said gives the system a total addressable market opportunity of $26 billion.

Is RNS surgery painful?

In March 2015, I had my surgery to place the RNS System. The actual surgical procedure was pretty easy and comfortable. The recovery was fine too. I didn’t have much pain, although I did experience some nausea after the surgery due to the fact that I don’t tolerate anesthesia very well.

What is the difference between RNS and VNS?

There are many important differences between VNS and the NeuroPace RNS System. First and foremost, VNS stimulates the vagus nerve in the neck whereas the NeuroPace RNS System is cranially implanted and stimulates preselected cortical epileptic foci in the brain.

What is the success rate of RNS?

The RNS device has “the potential to improve seizure control in patients with difficult to control epilepsy,” says neurological surgeon William Bingaman, MD, Head of the Section of Epilepsy Surgery at Cleveland Clinic. “Approximately 50% to 60% of patients have had good results.”

When did NeuroPace go public?

NeuroPace’s common stock is expected to begin trading on the Nasdaq Global Select Market on April 22, 2021, under the ticker symbol “NPCE”. The offering is expected to close on April 26, 2021, subject to the satisfaction of customary closing conditions.

Does VNS record seizures?

Every individual’s seizures are different and individual results will vary. Kimball has had the RNS System and VNS Therapy for 10 years each….

	The RNS System	VNS Therapy
Monitors & responds to brain activity	Yes	No
Records EEG data for your doctor to review	Yes	No

How long does RNS surgery take?

Surgery to implant the RNS system is performed under general anesthesia and typically takes between 2-4 hours. Many patients are able to go home the next day, and others can expect a 1-3 day hospital stay.