VNS Therapy receives FDA Approval for MRI labeling

23rd June 2017

LivaNova PLC

Enaie Azambuja

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Datasheet

LivaNova PLC has announced that its latest VNS Therapy systems (“VNS Therapy”) 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% 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 optimise treatment. Additional benefits include:

• improving ease of use and access to care

• eliminating the need for special MRI equipment

• providing comprehensive treatment throughout a patient’s lifetime

“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.

Individual results may vary. Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing.