With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the London-based company said.
“The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies. 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,” NA prez & neuromod GM Jason Richey said in a press release.
“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. 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,” CEO Damien McDonald said in a prepared statement.
In May, LivaNova saw shares rise after the medical device maker beat EPS expectations on Wall Street with its 1st quarter results.
The company posted profits of $11.3 million, or 23¢ per share, on sales of $285.1 million for the 3 months ended March 31, seeing a 128% swing from the red on the bottom-line while sales shrunk 0.7% compared with the same period last year.