Investigator-Initiated Research

What is 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 which include the use of LivaNova products. 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

Early vs Late use of VNS in DRE: Retrospective analyses evaluating clinical outcomes and healthcare utilization in patients with DRE receiving early (for example: within 5 years of DRE onset) versus late (including post-resection) intervention with VNS Therapy.
Optimization of VNS settings: Case series of optimization of VNS settings and titration schedules on seizure control and adverse event profile with a special interest in pediatric outcomes.
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.
VNS response prediction: Proof of concept studies utilizing biomarkers of response to VNS. Response includes identifying ideal candidates for VNS, predicting seizure response, QoL response, or improvement in comorbidities.
Assessment and optimization of patient care pathway and time to appropriate surgical interventions.
Exploratory indications: Case series and retrospective studies exploring additional benefits of VNS Therapy.

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.
Societal impact outcomes of interest include education, employment, productivity and socio-economic impact of DRE on caregivers and patients.
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.

Advanced Circulatory Support

We are not currently accepting IIR applications for the ACS program for 2024.

Cardiopulmonary

Demonstrate the impact of predictive and/or advanced CPB monitoring technologies on reducing adverse outcomes.
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.
Analyze advanced datasets using LivaNova technology to enable the development of models, which can positively impact clinical and economic outcomes.

To be eligible to receive support for IIR, the following conditions must be met:

The research for which support is being sought must be within the therapeutic areas that are served by LivaNova. Proposals that are aligned with the areas of interest set out above will receive the highest priority for review and funding.
Applications must be submitted by or on behalf of a legal entity/organization - funds/products can only be provided to organizations, and not individuals acting on their own.
All required information and supporting documentation must be provided. LivaNova may reach out to the applicant with follow up questions in relation to the provided material. Incomplete requests may be rejected or delayed.

Examples of Requests that are Out of Scope for IIRs:

General educational & training activities unrelated to the use of a LivaNova product
Support for clinical activities that are part of LivaNova’s routine operations
Start-up funds to establish new clinical or research programs unrelated to the use of a LivaNova product
Purchases of capital equipment
Construction funds to build new facilities
Payment for research staff time that is not dedicated to an IIR
Direct payments to Principal Investigators for writing and submitting publications of a clinical trial
Support for LivaNova Sponsored clinical studies
In-kind product donations that are not intended to be used for scientific research

How to Request IIR Support:

In order to request IIR support for research that involves the use of LivaNova devices, an IIR Project Proposal form (including supporting documentation) and an IIR Budget form must be submitted to the corresponding email address noted on the IIR Project Proposal form.

To make a request for educational grants, research grants that serve a genuine medical-scientific purpose and do not involve any LivaNova product, brand or influence, or charitable donations/indigent care, please visit our Donations and Grants page and complete the corresponding application.

Important Dates and Deadlines

Requests for IIR support are reviewed periodically throughout the year. Please see below for application deadline and review cycles.

Applications accepted until:	Notification of decision by:
March 29, 2024	May 30, 2024
June 28, 2024	August 30, 2024
September 30, 2024	December 2, 2024

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 in alignment with Fair Market Value (FMV). For additional information, please contact livanova.iir.nm@livanova.com for requests related to the LivaNova Neuromodulation portfolio, livanova.iir.acs@livanova.com for requests related to Advanced Circulatory Support and livanova.iir.cp@livanova.com for the Cardiopulmonary portfolio.