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Date Issued: March 9, 2017

Audiences:

• Organ and tissue procurement organizations
• Organ and tissue transplantation centers
• Health Care Providers who conduct organ and tissue transplant procedures
• Health Care Providers who care for organ and tissue transplant recipients
• Operating Room Managers, Directors and Staff
• Risk Managers
• Patients considering organ or tissue transplantation
• Organ and tissue recipients

Medical Specialties: Transplant surgeons,

The UK National Institute for Health and Care Excellence (NICE) completed a comprehensive review of the literature regarding normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death. This review comes following published and unpublished research trials using the Transmedics Organ Care System.

Heart transplantation usually involves hypothermic storage of donor heart until it

1. Cedars-Sinai Medical Center

2. Stanford University Medical Center

3. Vanderbilt University Medical Center

4. The Hospital of the University of Pennsylvania

5. UCLA Medical Center

6. New York-Presbyterian/Columbia

7.

Hibernicor’s Asporto // Heart Preservation Device has undergone a design upgrade improving the usability and functionality of the heart container. This improvement follows proof-of-concept testing done at the University of Minnesota Experimental Surgical Services laboratories. The Asporto device provides perfusion of cardioplegia to the donor heart using a computer-controlled peristaltic pump in a thermoelectrically

Docket Number: FDA-2012-N-1021

Docket Name: Food and Drug User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Years Proposed Guidance Document

Dr. Andrew Rivard’s response to FDA invitation to comments on utilizing animal studies to evaluate the safety of organ preservation devices and solutions:

What are the potential limitations of an

Hibernicor LLC has initiated a project with the George Mason University to analyze over a million records of nationwide heart transplant data provided by the United Network of Organ Sharing (UNOS) to determine if there are any regional differences in cold ischemia time