LivaNova PLC (LivaNova) operates as a global medical technology company. The company designs, develops, manufactures, markets, and sells products and therapies that are consistent to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions.
Segments
The company operates through two segments: Cardiopulmonary and Neuromodulation.
Cardiopulmonary segment
Cardiopulmonary segment engages in the desi...
LivaNova PLC (LivaNova) operates as a global medical technology company. The company designs, develops, manufactures, markets, and sells products and therapies that are consistent to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions.
Segments
The company operates through two segments: Cardiopulmonary and Neuromodulation.
Cardiopulmonary segment
Cardiopulmonary segment engages in the design, development, manufacture, marketing, and sale of cardiopulmonary products, including HLMs, oxygenators, autotransfusion systems, perfusion tubing systems, cannulae, and other related accessories. In particular, the Cardiopulmonary segment includes the Essenz Perfusion System, the company’s next-generation HLM with an embedded patient monitor for tailored patient care strategies, and sensing technology for data-driven decision-making during CPB procedures.
CPB is frequently utilized in various heart-related procedures. This method allows the surgical team to oxygenate and circulate the patient's blood, providing the necessary conditions for the surgeon to operate on the heart. The procedures most commonly requiring CPB include traditional coronary artery bypass grafting and valve surgeries. LivaNova’s products enable CPB for neonatal, pediatric, and adult patients.
Heart-lung Machines
The HLM product group includes HLMs, heater-coolers, related cardiac surgery equipment, and maintenance, as well as technical services. HLMs temporarily take over the heart and/or lung functions, providing and circulating blood and oxygen to the body while the heart is stopped during a cardiac surgery procedure. Heater-coolers are used during surgeries to warm or cool patients as part of their care. They are especially important during surgeries involving the heart and lungs.
Oxygenators and Perfusion Tubing Systems
The oxygenators product group comprises disposable devices for extracorporeal circulation, including the Inspire systems. The Inspire range of products comprises 12 models that provide perfusionists with a customizable approach for the benefit of patients. Oxygenators exchange oxygen and carbon dioxide in the blood of patients during surgical procedures and are utilized by perfusionists during cardiac surgery in conjunction with an HLM, and can also be utilized in ECMO.
Autotransfusion Systems
One of the key elements for a complete blood management strategy is autologous blood transfusion. The autotransfusion product group facilitates the collection, processing, and reinfusion of the patient’s own blood lost at the surgical site.
Cannulae
The cannulae product group comprises cardiopulmonary bypass cannulae, or tubing, which is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and interconnect the catheters and cannulae with an oxygenator.
Neuromodulation segment
Neuromodulation segment engages in the design, development, manufacture, marketing, and sale of devices that deliver neuromodulation therapy for treating DRE and DTD. LivaNova’s principal Neuromodulation product, the VNS Therapy System, consists of an implantable pulse generator and connective lead that stimulates the vagus nerve, surgical equipment to assist with the implant procedure, and equipment and instruction manuals that enable a treating physician to set parameters for a patient’s pulse generator.
The Neuromodulation segment is also engages in the development and management of clinical testing for LivaNova’s aura6000 System for treating OSA. The aura6000 device stimulates the hypoglossal nerve, which engages specific tongue and palate muscles to open the airway while a patient sleeps.
Epilepsy
There are several broad types of treatment available to patients with epilepsy: multiple ASMs, various forms of the ketogenic diet, VNS, resective and ablative brain surgery, and intracranial neurostimulation. ASMs typically serve as a first-line treatment and are prescribed for virtually all patients diagnosed with epilepsy. After two ASMs fail to deliver seizure control, the epilepsy is characterized as drug-resistant, and adjunctive non-drug options are considered, including VNS therapy, ketogenic diet, surgery, and other neuromodulation therapies.
LivaNova's VNS Therapy System is the first medical device treatment approved by the FDA for the treatment of DRE. VNS Therapy System is the only neuromodulation device approved for use in the U.S. in DRE patients as young as four years of age with partial onset, or focal, seizures. Other worldwide regulatory bodies have also approved the VNS Therapy System for treating patients with DRE, many without age or seizure-type restrictions. CMS expanded reimbursement for VNS Therapy use in the treatment of Dravet Syndrome. In January 2022, expanded reimbursement for VNS Therapy use in the treatment of Lennox-Gastaut Syndrome.
LivaNova distributes multiple VNS Therapy devices for the treatment of epilepsy, including Model 103 (Demipulse), Model 106 (AspireSR), Model 1000 (SenTiva), and Model 1000D (SenTiva Duo) pulse generators. LivaNova’s AspireSR and SenTiva implantable pulse generators provide the traditional benefits of VNS therapy but add an additional stimulation capability: closed loop stimulation (AutoStim), which responds to detection of changes in heart rate potentially indicative of a seizure. The SenTiva generator is the smallest and lightest VNS device capable of delivering responsive therapy for epilepsy and includes the additional flexibility of LivaNova’s Scheduled Programming and Day & Night Programming capabilities. In 2017, the SenTiva and AspireSR VNS Therapy devices were approved by the FDA for expanded MRI access, and similar CE Mark approval followed shortly thereafter.
Depression
VNS Therapy received CE Mark approval in 2001 for treatment-resistant depression in the EU. In 2005, the FDA approved the VNS Therapy System for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. In 2007, CMS issued an NCD stating that vagus nerve stimulation is not covered for treatment-resistant depression, significantly limiting access for most patients.
In 2023, LivaNova randomized the 500th unipolar depression patient into the RECOVER clinical study and completed enrollment in the unipolar cohort. In June 2024, the company announced the preliminary results for the unipolar patient cohort. The study did not meet its primary endpoint for the unipolar cohort; however, statistically significant and clinically meaningful improvements were achieved in select secondary endpoints. No new safety issues were identified in the study.
In December 2024, Brain Stimulation published two articles chronicling the unipolar cohort data set for the RECOVER clinical study. The articles concluded that active VNS Therapy, as compared with a no-stimulation control (or sham VNS Therapy), safely and effectively demonstrated clinically meaningful therapeutic effects on depressive symptoms and positive effects on quality of life and daily function. Analyses of secondary endpoints revealed antidepressant benefits significantly favoring active VNS Therapy as opposed to sham VNS Therapy as measured by ratings from on-site clinicians, patients themselves, and off-site masked raters. These findings support the use of VNS Therapy in patients with DTD. Based upon these findings and the positive effects for those who received VNS Therapy, the company conducted additional in-depth data analyses and expects to publish three additional critical manuscripts to report on the outcomes. The company intends to continue pursuing CMS coverage while reducing investment in the DTD program in 2025.
Obstructive Sleep Apnea
In 2018, LivaNova acquired full ownership of ImThera, a company developing an implantable neurostimulation device system for the treatment of obstructive sleep apnea. The device stimulates the hypoglossal nerve, which engages specific tongue and palate muscles to open the airway while a patient sleeps.
In 2021, LivaNova received approval from the FDA to proceed with its investigational device exemption clinical study, the OSPREY clinical trial, and the first patient was implanted in March 2022 with the aura6000 System.
In November 2024, the company announced the OSPREY clinical study met its primary endpoints for efficacy and safety. LivaNova plans to submit the PMA application within the first half of 2025.
R&D
The company’s R&D investment consists of product design and development expenses, including technology, software, clinical study programs, and regulatory activities. LivaNova’s markets are subject to rapid technological advances, and as such, product improvement, software advancements, and innovation are necessary to maintain market leadership. The company directs its R&D efforts toward maintaining or achieving technological leadership in each of its markets to help ensure that patients using the company’s devices and therapies receive the most advanced and effective treatment available. LivaNova remains committed to developing technological enhancements and new uses for existing products, as well as less invasive and new technologies to address unmet patient needs. LivaNova continues to engage researchers to collect clinical and health economic evidence that supports regulatory filings and value dossiers, and to establish the value proposition to patients, physicians, and payers for its products.
Patents and Licenses
LivaNova’s proprietary intellectual property, including among others:
Trademarks for LivaNova’s Neuromodulation systems, the VNS Therapy System, and LivaNova’s proprietary pulse generator products: Model 102 (Pulse), Model 102R (Pulse Duo), Model 103 (Demipulse), Model 104 (Demipulse Duo), Model 106 (AspireSR), Model 1000 (SenTiva), Model 1000-D (SenTiva Duo), and Model 8103 (Symmetry).
Trademarks for LivaNova’s Cardiopulmonary products and systems: Essenz, S5, S5 Pro, B-Capta, Inspire, Heartlink, XTRA, 3T Heater-Cooler, Connect, and Revolution.
Trademarks for LivaNova’s advanced circulatory support systems: TandemLife, TandemHeart, TandemLung, ProtekDuo, LifeSPARC, ALung, Hemolung, Respiratory Dialysis, and ActivMix.
Trademarks for LivaNova’s obstructive sleep apnea system: ImThera and aura6000.
Markets and Distribution Methods
LivaNova sells its medical devices through a combination of direct sales representatives, agents, and independent distributors. Europe and the APAC region are the company’s largest international markets, with net revenue from these regions representing 18% and 13%, respectively, of total net revenue during the year ended December 31, 2024.
LivaNova’s marketing and sales strategy is focused on rapid, cost-effective delivery of high-quality products to a diverse group of customers worldwide, including perfusionists, neurologists, neurosurgeons, and other physicians, hospitals, and other medical institutions and healthcare providers. To achieve this objective, LivaNova’s sales team develops and preserves appropriate working relationships with customers, and the company cultivates and maintains close working relationships with professionals in the medical industry. These relationships provide LivaNova with a detailed understanding of therapeutic and diagnostic trends, developments, and emerging opportunities, which enable the company to respond to the changing needs of providers and patients. LivaNova actively participates in medical conferences and conducts comprehensive training and educational activities to enhance its presence in the medical communities it serves.
Competition
LivaNova’s primary medical device competitors in the Cardiopulmonary and Neuromodulation product groups are Terumo Medical Corporation, Maquet Medical Systems, Medtronic plc, Haemonetics Corporation, Spectrum Medical Limited, and NeuroPace, Inc..
Seasonality
The number of medical procedures incorporating LivaNova’s products is generally lower during the summer months, particularly in European countries, due to summer vacation schedules.
Discontinued operations
In 2024, the company completed the wind down of its ACS segment.
Government Regulation and Other Considerations
Each medical device the company seeks to distribute commercially in the U.S. must receive 510(k) clearance or pre-market approval (PMA) from the FDA, unless specifically exempted by the agency. The 510(k) process, also known as pre-market notification, requires the company to demonstrate that its new medical device is substantially equivalent to a legally marketed medical device.
The PMA process, which is more costly and rigorous than the 510(k) process, requires the company to demonstrate independently that a medical device is safe and effective for its intended use.
The company's worldwide business is subject to the U.S. Foreign Corrupt Practices Act of 1977 (the FCPA), the UK Bribery Act of 2010 (the UK Bribery Act), and other anti-corruption laws and regulations applicable in the jurisdictions where it operates.
History
LivaNova PLC was incorporated in 2015.