LivaNova PLC (NASDAQ:LIVN) ("LivaNova" or the "Company"), a market-leading medical technology company, today announced it received CE Mark for its Vagus Nerve Stimulation Therapy ("VNS Therapy") System comprised of the SenTiva generator and next-generation Programming System for the treatment of patients with drug-resistant epilepsy ("DRE"). The Company received FDA approval for the full VNS Therapy System in October 2017.
The SenTiva generator offers the smallest and lightest responsive therapy with a number of new advanced features for the treatment of DRE. SenTiva is the only device of its size to include the AutoStim Mode, also known as Seizure Response Mode, which is designed to detect seizures and automatically deliver an extra dose of therapy. The generator is also designed to collect and log events including a patient's body position and heart rate fluctuations.
The next-generation Programming System includes a small tablet and wireless programming wand compatible with the SenTiva generator and all LivaNova legacy VNS Therapy generators. When combined with SenTiva's smart technology, the Programming System provides several advanced options and makes delivering treatment easier and more efficient through personalized patient-centric features.
"CE Mark combined with recent FDA approval for the SenTiva generator and Programming System advances VNS Therapy treatment for patients with drug-resistant epilepsy across the globe," said Edward Andrle, LivaNova's General Manager of its Neuromodulation business franchise. "Not only is the new VNS Therapy System simpler to use, making drug-resistant epilepsy treatment easier, the SenTiva generator and Programming System work together to allow physicians to confidently deliver proven results through customizable, smart technology. After a successful launch in the U.S., we look forward to seeing European patients benefit from our latest technology advancements."
The new System's features include:
- Guided Programming Advanced technology allows physicians to quickly and confidently deliver a proven treatment with one touch.
- Scheduled Programming Physicians can safely program multiple therapeutic steps in one office visit; the generator will then gradually and automatically increase therapy without the need for the patient to return to the physician. Scheduled programming can be very helpful, since many patients with epilepsy are not able to drive. This feature may also allow the patient to achieve a target dosage sooner.
- Day-Night Programming Physicians have unrivalled flexibility to customize therapy for when their patients need it at specific times, day or night.
The new features will help improve patients' overall quality of life, make VNS Therapy easier to use and bring value to the healthcare system. Treatment with VNS Therapy can result in fewer seizures, shorter seizures and faster recovery; to date, it has been used by more than 100,000 patients globally.1
"SenTiva provides exciting advances in neuromodulation therapy for drug-resistant epilepsy. The smaller size and new programming features expand the range of patients we can treat," said Dr. David McCormick, Clinical Lead for Paediatric Neurosciences at King's College Hospital, London. "To that end, we are pleased to announce that the first SenTiva implant in a pediatric patient in Europe took place at King's College Hospital in London."
1. Data on file, LivaNova PLC, Houston, TX.
About VNS Therapy for Epilepsy
VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children. VNS Therapy is designed to prevent seizures before they occur and stop them if they do. It is a unique treatment approach developed for people with drug-resistant epilepsy-a condition that affects one in three people with epilepsy. For more information, visit www.VNSTherapy.co.uk
INTENDED USE/INDICATIONS 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.
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. Visit http://en.eu.livanova.cyberonics.com/safety-information to view safety and full prescribing information.
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, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs more than 4,500 employees, inclusive of approximately 900 employed by our CRM business franchise. 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
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe LivaNova's future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," "could," "seek," "guidance," "predict," "potential," "likely," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this news release are based on information presently available to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova's actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance or actions that may be taken by LivaNova and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond LivaNova's control.
All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this news release.
LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations Corporate Communications
Deanna Wilke, +1 (281) 727-2764
Director, Corporate Communications Products and Therapies
Melissa Rieger, +1 (412) 251-2172