VNS Therapy ontvangt CE Mark voor het uitbreiden van MRI Labeling
LONDON–(BUSINESS WIRE)– LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), een marktleider in de medische technologie, maakt vandaag bekend dat zijn laatst uitgebrachte VNS Therapy ®Systems (“VNS Therapy”) een CE Mark heeft gekregen voor het uitbreiden van MRI labeling. VNS Therapy is nu het enige implanteerbare apparaat voor de behandeling van epilepsie waarbij patiënten de hoge kwaliteit 1.5T en 3T scans krijgen zonder de hulp van speciale apparatuur.
“De CE Mark komt een maand nadat we de goedkeuring kregen van U.S. FDA voor dergelijke geëxpandeerde MRI labeling”, zegt Damien McDonald, LivaNova’s Chief Executive Officer. “Het krijgen van CE mark en toestemming van FDA om MRI labeling uit te breiden haalt de blokkades weg om zorg te verlenen aan epilepsiepatiënten met medicijnresistentie.
VNS Therapy Receives CE Mark for Expanded MRI Labeling
LONDON–(BUSINESS WIRE)– LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced its latest VNS Therapy ®Systems (“VNS Therapy”) received CE Mark for expanded MRI labeling. VNS Therapy is now the only implantable device indicated for epilepsy therapy that allows patients to have high-quality 1.5T and 3T MRI scans without the need for special equipment.
“The CE Mark comes one month after we received U.S. FDA approval for similar expanded MRI labeling,” said Damien McDonald, LivaNova’s Chief Executive Officer. “Earning CE Mark and FDA approval to expand our MRI labeling removes a barrier to care for patients with drug-resistant epilepsy.”
The labeling change applies to the latest VNS Therapy technology, which includes AspireHC ® and AspireSR ® devices. Now, patients who have or desire to have VNS Therapy can more easily receive routine MRI scans.
“In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient’s lifetime,” adds Jason Richey, LivaNova’s President of North America & General Manager of the Neuromodulation franchise.
To date, more than 100,000 patients worldwide use VNS Therapy—a minimally invasive treatment designed to prevent seizures before they start and stop them if they do. More than one in three people with epilepsy has drug-resistant seizures, meaning seizures persist in spite of treatment with antiepileptic medications. 1 To learn more, visit www.VNSTherapy.com orwww.SeizureControl.com.
INTENDED USE/INDICATION – EPILEPSY – EU
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.
AspireSR™ (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience cardiac rhythm increases that are associated with seizures.
Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing. Visit www.VNSTherapy.com/important-safety-information to view safety and full prescribing information.
1. Kwan P., Brodie M.J. New England Journal of Medicine. 2000;342:314-19.
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively.
For more information, please visit www.livanova.com .
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