Investigator-Sponsored Studies

Research Grants

Abiomed funds clinical research programs that investigate how mechanical circulatory support with Impella® heart pumps may improve patient outcomes.

All types of research programs will be considered for funding through Abiomed’s investigator-sponsored studies (ISS) office. ISS are clinical studies that are initiated, developed, and conducted by a qualified researcher external to Abiomed who assumes all legal and regulatory responsibility for the trial. Potential ISS programs are funded through a competitive review process. 

Areas of Interest

The following research domains have been identified by Abiomed to be areas of interest for innovation within the field. Applications within these domains will be given priority in the competitive application process. However, applications outside these domains will still be considered.

ECpella™

Studies involving combination of Impella and ECMO support investigating outcomes, hemodynamics and physiology

Access, Hemostasis and Anticoagulation

Managing procedural and long-term patient anticoagulation, vascular access techniques and patient outcomes

Long Duration Impella 5.5® with SmartAssist® Support

Outcomes and best practices for management in patients who require ongoing circulatory support (>14-day support, requires IDE approval)

Right Heart Failure

Early recognition and predictive metrics for identification and management of patients with RV dysfunction

Researchers interested in applying to Abiomed for competitive research funding should familiarize themselves with investigator expectations, Abiomed funding priorities, and the research grant review process. 

Competitive Review Process

Abiomed carefully evaluates all submitted proposals. The investigator-sponsored studies review board evaluates applications based on the following criteria:

  • Scientific and clinical impact
  • Alignment with established funding priorities
  • Innovation
  • Study design and methodology
  • Investigator experience & research site infrastructure
  • Feasibility 
  • Patient safety

Abiomed and investigators funded through the ISS office share a common goal of generating high quality data, protecting human subjects, complying with all regulatory requirements, and advancing science for human health.

 

Investigator-Sponsored Studies Responsibilities

Responsibilities

Sponsor-Investigator

Abiomed

Study design & research protocol development

X

 

Submission of Investigational Device Exemption (IDE) application (if required)

X

 

Study implementation & oversight

  • Participant inclusion
  • Obtaining proper informed consent
  • Compliance with protocol

X

 

Regulatory Submissions & Compliance

  • IRB/EC approvals
  • FDA submissions
  • Protocol amendment submissions
  • Continuing reviews
  • Final study reports
  • Safety reporting

X

 

Register study in a public database (e.g. clinicaltrials.gov)

X

 

Contract with third-party vendors

X

 

Database development & data analysis

X

 

Publications

X

 

Evaluates the proposed study for funding based on scientific merit and business alignment

 

X

Distributes updated, approved product information

 

X

Provides research grant award

 

X

Monitors trial progress in accordance with agreed upon milestones and protocol

 

X

Reviews protocol amendments

 

X

Reviews study manuscripts prior to publication

 

X

 

Investigator-Sponsored Study Application Process

1. Submit your complete application

You will be asked to submit an initial concept for review (Part A). If the initial concept is approved by Abiomed, a full study proposal (Part B) will be requested. You will be notified of your proposal status via email.

Part A: Concept Part B: Full Proposal

Required:

  • Cover letter
  • Study synopsis
  • Budget estimation
  • Principal investigator (PI) CV

Required:

  • Full protocol
  • Detailed budget with justification
  • PI current medical license
  • Co-investigator CVs
  • Enrollment projections

Recommended:

  • Case report forms
  • IRB/Ethics approval (if available)

Please note, only complete applications will be considered for review. Proposals submitted by email will not be considered.

 

2. Proposal Review & Determination

Initial concept proposals are reviewed on an on-going basis, and full proposals are reviewed quarterly. You will be promptly notified of Abiomed’s grant funding decision via email. If you have any questions regarding the process, or would like to speak to the investigator-sponsored studies program team regarding your new or existing application, please contact us at investigatorstudies@abiomed.com.

Proposal Review Session PI Notified of Result of Review By:
September 6, 2021 October 4, 2021
December 6, 2021 January 3, 2022
March 7, 2021 April 4, 2021
June 6, 2021 July 3, 2022

 

Begin Application

NPS-2030