Revolutionary therapy system has treated more than 120,000 patients worldwide
LivaNova PLC (LIVN), a market-leading medical technology company, is celebrating the 25th anniversary of its Vagus Nerve Stimulation Therapy® (VNS Therapy) System. This clinically proven, safe and effective therapy is used for the treatment of Drug-Resistant Epilepsy (DRE), Treatment-Resistant Depression (TRD) and for the delivery of Autonomic Regulation Therapy for Heart Failure.
“Celebrating 25 years of VNS Therapy is a significant milestone not only for our company, but for each patient VNS Therapy helps every day,” said Damien McDonald, Chief Executive Officer of LivaNova. “This is an important moment to commend the years of innovative work that have been put into this therapeutic system and celebrate the many lives it has transformed.”
The VNS Therapy System was approved in 1994 and is indicated as an adjunctive therapy in reducing the frequency of seizures that are refractory to seizure medications. Since then, it has become the number one implantable device for DRE—treating more than 120,000 patients including more than 30,000 children across the globe.
“At the worst point, I had over 20 seizures in one day and was rushed by jet to a hospital in another city. I had several brain surgeries there, and after the fourth surgery, it came to a point where I started to ask myself questions, like ‘What’s the purpose of living?’” said Casey, an epilepsy patient. “VNS Therapy helped bring my seizures under better control, and I feel like I’ve been given a second chance at life.”
In addition to helping prevent, stop or shorten seizures, the LivaNova VNS Therapy System is FDA and CE Mark approved for the treatment of TRD and is CE Mark approved for the treatment of Heart Failure. LivaNova is conducting and developing clinical trials to advance the treatment of patients in these areas of unmet need.
“While we are incredibly proud of the 25 years of success that patients and their doctors have seen with the VNS Therapy System in Drug-Resistant Epilepsy, there is significant opportunity for further application of this technology,” said Edward Andrle, General Manager of the LivaNova Neuromodulation business franchise. “We are actively working to generate clinical evidence demonstrating that VNS Therapy is safe and effective for patients with TRD and Heart Failure. We believe VNS Therapy can improve the quality of life for the millions of patients who suffer from these diseases.”
For more information about the LivaNova VNS Therapy System, visit the LivaNova website.
Important Safety Information
About VNS Therapy® for Epilepsy
VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children 4 years of age and older. 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 VNSTherapy.com.
INTENDED USE / INDICATIONS – UNITED STATES
Epilepsy—The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.
Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and decrease over time.
See safety information at VNSTherapy.com/safety.
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 approximately 4,000 employees. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), 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. You should carefully consider the risks and uncertainties that affect LivaNova, including those described in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission.
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