Hosted by IDTechEx
Global Biotechnology Insights
Posted on June 23, 2017 by  & 

VNS therapy receives FDA approval for expanded MRI labeling

LivaNova PLC, a market-leading medical technology company, announced that its latest VNS Therapy® systems received FDA approval for expanded MRI labeling, affirming VNS Therapy as the only epilepsy device approved by the FDA for MRI scans. This FDA approval ensures VNS Therapy patients with the latest technology may visit any MRI center in the U.S. and have access to more than 90 percent of scans routinely performed on patients with epilepsy.
 
"Our dedication to innovation has enabled LivaNova to remove a barrier for people with drug-resistant epilepsy who already have, or desire to have, the latest VNS Therapy technology based on its proven ability to deliver more seizure-free moments," said Damien McDonald, LivaNova's Chief Executive Officer. "Previously, our labeling allowed patients to obtain MRI scans only with the use of special MRI equipment that was not readily accessible. Now, this new approval simplifies the process and increases access of patients with our latest technology to any MRI center of their choice for the scans they need."
 
Currently, AspireHC® and AspireSR® models of VNS Therapy technology provide for this expanded MRI access, enabling patients to obtain high-quality MRI scans and optimize treatment.
 
 
"The FDA's approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies," adds Jason Richey, LivaNova's President of North America & General Manager of the Neuromodulation franchise. "This further differentiates our technology from other epilepsy treatment options and adds a new dimension in our ability to support patients' long-term treatment plans."
 
To date, VNS Therapy—a minimally invasive treatment designed to prevent seizures before they start and stop them if they do—has been used by more than 100,000 patients worldwide. More than one in three people with epilepsy has drug-resistant seizures, meaning seizures persist in spite of treatment with antiepileptic medications. It is estimated that approximately one million people suffer from drug-resistant epilepsy in the U.S. alone.
 
The VNS Therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.
 
VNS Therapy is delivered through a device that sends mild pulses to the vagus nerve at regular intervals throughout the day in an effort to stop seizures before they start. An additional dose of therapy may stop or shorten a seizure, decrease its intensity and shorten recovery time. VNS Therapy includes a short outpatient procedure which takes about an hour.
 
 
  • Standard Mode: Prevention Delivery - Therapy is delivered at regular intervals throughout the day in an effort to stop seizures before they start.
  • Detect & Respond: Responsive Delivery - Responsive automatic delivery of an extra dose of therapy (when a rapid increase in heart rate is detected that may be associated with seizures) in an effort to stop a seizure once it starts.
  • Magnet Mode: On-Demand Delivery - Provides you or a caregiver the ability to manually deliver an additional dose of therapy in an effort to stop a seizure once it starts.
 
Source and top image: LivaNova PLC
More IDTechEx Journals