Investigator-Initiated Research

Investigator Initiated Research (IIR) studies are designed and conducted independently by investigators who also serve as the study sponsor. As the sponsor, the investigator assumes all responsibilities for complying with applicable regulatory requirements. IIRs include any preclinical, clinical, technical, observational, economic or other research that serves a genuine medical-scientific purpose in the Neuromodulation or Cardiopulmonary field. IIR may be supported by LivaNova in the form of product, funding and/or technical input.

Key Areas of Interest for Investigator Initiated Research

Neuromodulation

1. Biomarker forecasting and measurement of seizures or response to therapy and/or application of AI and LLM to such biomarkers. 
2. Comorbidities: Case series and retrospective studies evaluating changes in mood, depression, and/or cognition using validated instruments in patients with DRE treated with VNS Therapy.
3. Exploratory indications: Note to applicants that Investigator Initiated Research that evaluates the use of a device that is not in accordance with the approved labeling requires prior approval from the relevant Competent Authority.

General Considerations

• Analysis of existing patient databases that have been systematically collected as part of an ongoing evidence generation program are highly desirable (for example The Epilepsy Learning Healthcare System (ELHS), pELHS (pediatric Epilepsy Learning Healthcare System), and International Consortium for Health Outcomes Measurement (ICHOM).
• Clinical outcomes of interest: seizure frequency, seizure severity, mortality, injury, quality of life (both disease specific and generic health status measures such as EQ5D), depression, cognition, loss of function, and failure to achieve developmental milestones (validated assessments preferred).
• Patient Reported Outcome Measures (PROMs) measuring the patients’ views of their health status are welcomed.
• Inclusion of Patient Reported Experience Measures (PREMs) measuring the patients’ perceptions of their experience are encouraged.
• Investigator Initiated Research that evaluates the use of a device that is not in accordance with the approved labeling requires prior approval from the relevant Competent Authority. See LivaNova’s Physician Manual and product labeling for a full listing of Indications, Contraindications, Warning and Precautions.

Cardiopulmonary

1. Demonstrate the impact of predictive and/or advanced Extracorporeal Circulation monitoring technologies on reducing adverse outcomes.
2. Demonstrate benefits of Essenz Perfusion System data management and workflow strategies for multi-center, national or international benchmarking on pre, peri and post procedural patient characteristics and outcomes.
3. Analyze advanced datasets using LivaNova technology to enable the development of models, which can positively impact clinical and economic outcomes.

All proposals must be submitted using LivaNova’s MedCompli portal.

This Quick Reference Guide outlines the process for registering and submitting Investigator-Initiated Research applications through the MedCompli Portal, LivaNova’s official system of record for all funding requests.

Submissions will be reviewed by the Research Committee based on scientific merit, strategic fit, study feasibility, investigator’s qualification, and clinical relevance. All budgets must be aligned with Fair Market Value (FMV).

For additional information, please contact livanova.iir.nm@livanova.com for requests related to the LivaNova Neuromodulation portfolio and livanova.iir.cp@livanova.com for the Cardiopulmonary portfolio.

To make a request for educational grants or charitable donations/indigent care, please visit our Donations and Grants page.

Submit Proposal