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The Majority of Donated Organs Are Not Utilized for Transplantation Due To The Limitations Of Cold Storage Preservation

Only 2 out of 10 lungs are used

Only 3 out of 10 hearts are used

Every organ wasted is a life not saved.

Sources: Organ Procurement and Transplantation Network; Global Observatory on Donation and Transplantation; Institute of Medicine of the National Academy of Science (2006).

The Current Limitations of Cold Storage Preservation

Unfortunately, most donated organs cannot be used. This is in part due to the current limitations of cold storage organ preservation (putting organs on ice in a cooler).

COLD ISCHEMIA

Donated organs placed on ice remain viable only for a limited amount of time. Being maintained in this ischemic state, with no blood supply, for an extended period of time can result in permanent organ damage.

NO ORGAN ASSESSMENT

Because organs placed in cold storage are neither functional nor metabolically active, they cannot be assessed for viability.

LACK OF ORGAN OPTIMIZATION

Therapeutic intervention cannot be used to optimize the condition of donor organs, which may negatively impact transplant outcomes.

A Transformative Technology

To overcome the limits of cold storage, the Organ Care System, or OCS™, is a transformative technology designed to better preserve, assess, and maintain donor organs, potentially reducing the number of unused organs by addressing the key limitations of current preservation methods.

WARM BLOOD PERFUSION

Donor organs are maintained in a living, functioning state, perfused with warm, oxygenated, and nutrient-enriched blood

ORGAN ASSESSMENT

The OCS allows physicians to monitor and assess the viability of organs outside the body

THERAPEUTIC INTERVENTION AND OPTIMIZATION

By replenishing organs with oxygen and nutrients, the health of an organ can be optimized during transport

TransMedics Organ Care Systems

Frequently Asked Questions

HOW ARE DONOR ORGANS MAINTAINED TODAY?

In the past, maintaining donor organs has been limited to cold ischemic storage. “Ischemic” means that the organ lacks an oxygenated blood supply. In cold ischemic storage, organs are transferred to a plastic bag and placed inside a cooler filled with ice. This storage method is not sufficient to maintain viable tissue for longer than a few hours. This low-technology method of maintaining donor organs on ice limits the overall distance organs can safely travel and is correlated to post-transplant complications.

OCS is a portable organ preservation system that creates a warm, oxygenated, and nutrient-rich environment for donor organs. By nourishing organs in a state that mimics the human body, OCS can give transplant teams the potential to improve post-transplant outcomes and save more lives.

WHAT ARE THE LIMITS OF COLD STORAGE?

Unfortunately, the majority of organs donated do not end up being used because of the damage associated with cold ischemic storage. The most significant limitations include:

  • The narrow window of time allowed for “safe” organ transport
  • The potential for organ damage to occur. Even within “safe” time limits, injury can occur due to cold ischemia
  • Inability to test the organ for function. Once an organ is put in a cooler, there’s virtually no way to check or maintain its condition

The OCS can preserve organs and provide a way for transplant teams to assess organ function before transplant.

HOW DOES THE OCS REDUCE ISCHEMIC TIME?

By pumping warm, oxygenated, nutrient-rich blood through the organ from the time it is removed until it is implanted, the OCS makes it possible for an organ to withstand longer periods of time outside of the body and be less vulnerable to damage during transportation.

The OCS offers advantages over cold storage.

HOW DOES THE OCS MAINTAIN ORGAN QUALITY?

The OCS replenishes an organ with nutrient-enriched fluids which, when combined with donor’s blood can help maintain the overall health of donor organs during transport, of donor organs during transport.

The OCS replenishes donor organs during transport to help maintain organ condition prior to transplantation.

HOW IMPORTANT IS REAL-TIME MONITORING OF DONOR ORGANS?

Monitoring organs has never been possible with cold storage and is the primary reason why organs donated after circulatory death are rarely used for lung transplantation, and never used for heart transplantation.

The OCS enables real-time monitoring of donor organs and provides transplant teams with greater insights into organ viability. 

IS THE OCS SUPPORTED BY CLINICAL AND REAL-WORLD EXPERIENCE?

TransMedics has a substantial body of clinical evidence.

Leading transplant programs worldwide have supported this body of evidence   Our clinical trials and studies have been published in numerous peer-reviewed publications

The clinical evidence for OCS can be accessed in Publications.  

HOW DOES THE OCS INCREASE THE AVAILABILITY OF ORGANS?

Even with approximately 67,000 potential donors worldwide, the majority of hearts and lungs donated after brain death go unutilized, while almost no available lungs or hearts can be donated after circulatory death.

OCS Heart has shown 81% successful usage of donor hearts vs 32% via cold storage in the EXPAND trial

The OCS has the potential to increase utilization of these organs, while improving post-transplant outcomes for patients.

 

Source: US Organ Procurement and Transplant Network (OPTN) 2016 Annual Report