LivaNova Launches SenTiva DUO

Rhea-AI Summary

LivaNova PLC has launched the SenTiva DUO, an implantable pulse generator designed to provide VNS Therapy for drug-resistant epilepsy. This new device features a dual-pin header, allowing existing patients with dual-pin systems to upgrade without lead revision. It maintains the therapeutic advantages of the original SenTiva, including automatic seizure response and programmable therapy options. The device has received 510(k) clearance from the U.S. FDA and is now available in the U.S. market, aiming to enhance patient care for those requiring advanced epilepsy treatment.

Positive

• Launch of SenTiva DUO expands treatment options for VNS Therapy patients.
• SenTiva DUO allows existing patients to upgrade without lead revision.
• Maintains therapeutic features comparable to the original SenTiva.
• 510(k) clearance from U.S. FDA improves market accessibility.

Negative

• None.

New device expands access to the latest technology for legacy VNS Therapy patients with drug-resistant epilepsy in the U.S.

LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today launched SenTiva DUO™, an implantable pulse generator (IPG) with a dual-pin header to provide VNS Therapy™ for the treatment of drug-resistant epilepsy. The dual-pin header distinguishes this latest IPG from the original SenTiva™, which is only available in a single-pin format. Now, with SenTiva DUO, patients considered “the pioneers of VNS Therapy” who were originally implanted with a dual-pin lead and IPG can receive the benefits of the latest VNS Therapy technology.

LivaNova's SenTiva DUO™, an implantable pulse generator with a dual-pin header to provide VNS Therapy™ for the treatment of drug-resistant epilepsy. (Photo: Business Wire)

“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.”

SenTiva DUO received 510(k) clearance from the U.S. Food and Drug Administration and 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.

About LivaNova

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.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding VNS Therapy, SenTiva DUO and SenTiva. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230131005958/en/

LivaNova Investor Relations and Media Contacts

+1 281-895-2382

Briana Gotlin

Director, Investor Relations

InvestorRelations@livanova.com

Deanna Wilke

VP, Corporate Communications

Corporate.Communications@livanova.com

Source: LivaNova PLC

FAQ

What is the SenTiva DUO launched by LivaNova?

The SenTiva DUO is an implantable pulse generator for VNS Therapy designed for patients with drug-resistant epilepsy.

How does SenTiva DUO differ from the original SenTiva?

SenTiva DUO features a dual-pin header, allowing legacy patients to upgrade without lead revisions, unlike the single-pin original.

When did LivaNova get FDA clearance for SenTiva DUO?

SenTiva DUO received 510(k) clearance from the U.S. FDA prior to its launch.

Where is SenTiva DUO available?

SenTiva DUO is currently available in the United States.

What benefits does SenTiva DUO provide to patients?

SenTiva DUO offers automatic therapy customization, optimal seizure control, and advanced programming options.