Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)

Overview

To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

Description

To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

Eligibility

• ≥18 years of age.
  • Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.
  • De novo liver transplant recipient.
  • Written informed consent required.

Exclusion Criteria:

• Subject is a multi-organ transplant recipient.
• Subject is antibodies blood group (ABO) liver incompatible.
• Subject has severe systemic infection.
• Subject is Human Immunodeficiency Virus (HIV) positive.
• Subject has acute/fulminant liver failure.
• Subject is pregnant.