NeuroPace RNS System Receives FDA Approval for MRI Labeling, Allowing Thousands More Patients to Benefit from Personalized, Data-Driven Epilepsy Treatment

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that its RNS® System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling for the RNS System, expanding treatment options for the approximately one million patients in the United States living with seizures that do not respond to medication.

Individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option. This will also allow people to receive the RNS System before committing to an irreversible surgery such as laser ablation, while keeping their future treatment options open.

“MRI conditional labeling opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging (MRI) scans under appropriate conditions,” said Michael Favet, President and CEO of NeuroPace. “I’m pleased that we have removed a potential barrier to treatment and increased the number of patients who can benefit from this life-changing therapy.”

“The approval decision is wonderful news for the many people living with refractory epilepsy. This therapy not only reduces seizures, it also empowers clinicians with data-driven insights into their patients’ epilepsy,” said David Burdette, M.D., section chief of epilepsy at Spectrum Health, Grand Rapids, Michigan.

Treatment with the RNS System has been shown in a real-world, multi-center retrospective study to deliver outcomes never before seen with any neuromodulation device for epilepsy. Patients saw median seizure frequency reduction of 82% at 3 years, and 1 in 3 patients achieved 90% or greater seizure reduction.1 In addition to therapeutic benefits, the RNS System is the only epilepsy treatment that captures direct, real-world EEG data, enabling clinicians to personalize and optimize therapy over time.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.