LivaNova, a leading medical tech and innovation firm, launches SenTiva DUO, an IPG with dual-pin header for treatment of drug-resistant epilepsy via VNS Therapy. SenTiva DUO distinguishes itself from the original SenTiva (single-pin) and provides latest VNS Therapy technology to patients originally implanted with dual-pin lead and IPG.
“This new offering enables those VNS Therapy patients with legacy dual-pin systems to have the option to replace their device with SenTiva DUO, delivering the most advanced VNS Therapy treatment without the need for lead revision,” said Dr. James Wheless, Professor and Chief, Pediatric Neurology, Le Bonheur Children’s Hospital in Memphis, Tennessee. “Having access to SenTiva DUO offers patients therapy that can be customized and delivered automatically, providing optimal seizure control and enabling maximum adherence to treatment.”
SenTiva DUO offers the same therapeutic benefits as SenTiva. Both provide stimulation in response to rapid heart rate increases, which may be associated with seizures; allow Day-Night Programming; offer Scheduled Programming; and log low heart rate and prone position events.
“We’re proud to offer SenTiva DUO to serve patients who were early adopters of VNS Therapy many years ago,” said Damien McDonald, Chief Executive Officer of LivaNova. “Over time, all VNS Therapy patients must replace their generators as batteries become depleted. Now, our ‘pioneer patients’ will be able to take advantage of the latest technology with SenTiva DUO and experience the full benefits of VNS Therapy, without the need to replace their dual-pin lead.”
LivaNova received approval for its SenTiva DUO premarket approval (PMA) supplement from the U.S. Food and Drug Administration, and the device is currently available in the United States.
About VNS Therapy for Epilepsy:
VNS Therapy is clinically proven safe and effective as an add-on treatment for drug-resistant epilepsy in adults and children as young as 4 years old with partial onset seizures. 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 approximately one in three people with epilepsy. For more information, visit VNSTherapy.com.
INTENDED USE/INDICATIONS – UNITED STATES
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. Incidence of adverse events following stimulation (>5%) were voice alteration, increased coughing, hoarseness, shortness of breath, sore throat and nausea. Infection is the most common adverse side effect of the surgical procedure. See important safety information at VNSTherapy.com/safety.
LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 3,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide.
For more information, please visit www.livanova.com.