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. IIR may be supported by LivaNova in the form of product, funding and/or technical input.
Key Areas of Interest for Investigator Initiated Research
(1) Early vs Late use of VNS in DRE: Studies that evaluate 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.
(2) Optimization of VNS settings: Studies that evaluate clinical or electrophysiologic outcomes in patients using different VNS Therapy parameters or titration regimens.
(3) Biomarkers: Studies that evaluate mechanisms of action of VNS Therapy; neurophysiological correlates of VNS efficacy, side effects or response probability; and potential biomarkers useful for seizure monitoring including but not limited to in home monitoring and/or wearable technology.
(4) Comorbidities: Studies that evaluate changes in mood, depression, and/or cognition using validated instruments in patients with DRE treated with VNS Therapy.
(5) Exploratory indications: Proof of concept studies to explore possible benefits of VNS Therapy outside of epilepsy.
General considerations for all areas of interest:
- Analysis of existing patient databases that have been systematically collected as part of an ongoing evidence generation program are highly desirable.
- 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, and productivity are also 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.
Advanced Circulatory Support
(1) Studies that quantify the outcomes of RA-PA Dual Lumen Cannulation with oxygenation in patients with acute respiratory failure. Clinical and economic outcomes to quantify and compare the efficacy and safety of ProtekDuo vs conventional veno-veno cannulation. Clinical outcomes including early ambulation, RV function, mechanical ventilation dependency, ability to connect or disconnect the oxygenator without interruption of support, ICU length of stay, total length of stay, recovery time, hospital costs, staff dependency, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.
(2) Studies that compare VA-ECMO using LifeSPARC to other temporary percutaneous heart pumps in patients with acute cardiac insufficiency. Clinical and economic outcomes to quantify and compare the efficacy, safety, and healthcare utilization for patients treated with LifeSPARC compared to other heart pumps. Clinical outcomes including time to ambulation, blood product use, central venous pressure, recovery time, ICU length of stay, total length of stay, hemodynamic parameters, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.
(3) Usability studies that evaluate the implementation of an ECMO program utilizing LifeSPARC. Usability and clinical outcomes to quantify and compare the ease of use of the ECMO program using LifeSPARC. Outcomes including set up time, rapid initiation, number of FTE required to implement the program, staff dependence (total cost of support staff). Key interests include the correlation of rapid initiation and with clinical and economic outcomes, number of staff to manage the device and patient post insertion, cost savings compared to conventional programs.
To be eligible to receive support for IIR, the following conditions must be met:
1) 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.
2) 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.
3) 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.
In order to request IIR support for research that involves the use of LivaNova devices,
Download the request form here
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.
**UPDATE: Applications for the September 30, 2022 deadline are limited to product requests to support pre-clinical studies. No other applications are being accepted at this time.**
|Applications accepted until:
||Notification of decision by:
|March 31, 2022
||May 30, 2022
|June 30, 2022
||August 31, 2022
|September 30, 2022
||December 2, 2022
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 firstname.lastname@example.org for requests related to the LivaNova Neuromodulation portfolio or email@example.com for requests related to the Advanced Circulatory Support or Cardiopulmonary portfolio.