The well-known market-leading medical tech firm, LivaNova Plc., declared this week that its new VNS Therapy® network (VNS Therapy) got FDA endorsement for extended Magnetic Resonance Imaging label, making VNS Therapy as the sole epilepsy gadget accepted by the FDA for Magnetic Resonance Imaging scans. This approval by the FDA makes sure that VNS Therapy patients with the new technique may visit any Magnetic Resonance Imaging center in the U.S. and have authorizations to over 90% of scans performed with epilepsy routinely on patients.
“Our devotion to innovation has allowed LivaNova to get rid of a barrier for individuals with drug-resistant epilepsy who desire to have or already have, the new VNS Therapy technique based on its established capability of delivering more moments that are seizure-free,” claimed LivaNova’s Chief Executive Officer, Damien McDonald. “Earlier, our labeling permitted patients to have Magnetic Resonance Imaging scans only with the help of special Magnetic Resonance Imaging tool that was not easily accessible. Today, this new approved device eases the procedure and surge the access of patients with our new technique to any Magnetic Resonance Imaging center for the scans of their choice they want.”
At present, AspireSR® and AspireHC® models of VNS Therapy technique offers this expanded Magnetic Resonance Imaging access, allowing patients to gain high-quality Magnetic Resonance Imaging scans and enhanced therapy. Additional benefits include:
- Eliminating the want for particular Magnetic Resonance Imaging tool
- Improving access to care and ease of use
- Providing comprehensive treatment throughout the lifetime of a patient
“The approval from the FDA to extend our Magnetic Resonance Imaging label modifies the landscape for gadget-based epilepsy treatments,” adds LivaNova’s General Manager of the Neuromodulation franchise and President of North America, Jason Richey. “This further distinguishes our techniques from other epilepsy therapy choices and puts a new dimension in our capability of supporting long-term treatment plans for patients.”
Till now, VNS Therapy—an austerely invasive therapy developed to avoid seizures prior to their starting and stopping—has been utilized by over 100,000 patients globally. Over 1 in 3 individuals with epilepsy has anti-drug seizures, sensing that seizures persevere in spite of therapy with medicines that are antiepileptic in nature. It is expected that about 1 Million people in the U.S. alone undergo from drug-resistant epilepsy.
Well, for now, the good news is that VNS Therapy by LivaNova Plc. for extended Magnetic Resonance Imaging label has been approved by the FDA.