Pivotal Trial for Heart Transplantation

PROCEED II is a global clinical trial 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
Continuous Monitoring of the Donor Heart		Clinical Principles Designed to eliminate injury caused by lack of blood supply Allows the beating heart to be continuously monitored until transplant

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 October 2011, there have been 125 OCS HEART transplants on both a commercial and trial basis in Europe and on a trial basis in the U.S.

 INVESTIGATIONAL DEVICE: Not commercially available in the U.S.