PROCEED II is a clinical trial in the U.S. that compares standard cold storage of donor hearts
to warm oxygenated blood perfusion using the Organ Care System.

Heart in Cold Storage

Heart Supported on the Organ Care System

THE ORGAN CARE SYSTEM (OCS™) The Organ Care System maintains donor hearts in a near physiologic beating state outside of the human body. The heart is supplied with warm oxygenated blood that is supplemented with nutrients and electrolytes that have the potential to maximize benefits and protect the heart from damage.

OCS Supplies the Heart with Blood

PROCEED II Trial Design

128 patients may participate in the trial. There is a 50% chance that a participant will receive a heart transported using the OCS and
a 50% chance the heart will be transported under cold storage conditions. The success of the trial will be measured by primary and secondary endpoints.

Primary Endpoint:

• 30-day patient & graft (transplanted heart) survival

Secondary Endpoints:

• Incidence of cardiac-related serious adverse events
• ICU time
• Incidence of acute rejection episodes

Cumulative OCS Clinical Experience

As of July 2010, there have been 100 OCS heart transplants in both Europe and the U.S.