European clinical trial of beating heart transplant system
14 March 2006
Andover, Mass. USA. TransMedics, Inc., has initiated the European PROTECT
clinical trial for its Organ Care System, the only system that allows a new
type of organ transplant, called a living organ transplant.
The PROTECT trial is the prospective multi-centre European trial to
evaluate the safety and performance of the Organ Care System for heart
transplants. The current trial sites are; Clinic for Thoracic &
Cardiovascular Medicine, Bad Oeynhausen and the German Heart Institute in
Berlin, Germany, as well as Papworth Hospital, Cambridge, UK and Harefield
Hospital, Middlesex, UK.
The primary endpoint is the seven-day patient survival rate following
transplant. All patients will be followed for 30 days for further data.
Long-term patient survival and other outcome measures will be tracked
through established registries.
TransMedics' Organ Care System maintains organs in a functioning state
outside the human body to optimize their health, allowing real-time clinical
evaluation for the first time. Warm, oxygenated, nutrient-rich blood is
perfused through the organ from the time of removal until it is implanted,
maintaining the heart in a warm, functioning state outside the body until it
is ready for implantation. This process may allow the organ to withstand
longer periods of time outside of the body and be less vulnerable to damage
during transportation to the recipient.
"The benefits of warm versus currently utilized cold storage in
preventing cell death and ensuring healthier organs have long been
understood. TransMedics is the first to make warm storage a reality," said
Prof. Dr. Dr. Reiner Korfer of Bad Oeynhausen Clinic for Thorax - and
Cardiovascular Surgery. "The TransMedics approach is a truly revolutionary
advance in a crucial surgical field."
The Organ Care System optimizes the organ's health and allows for
continuous clinical evaluation. Physicians can perform visual, functional
and metabolic assessment of the organ, to reduce the risk of organ rejection
and increase the number of organs accepted for transplant. Current cold
ischemic preservation and transportation methods — which essentially consist
of transporting the organ in an ordinary beverage cooler — create severe
time limitations, as well as potential injury to the organ, resulting in
significant underutilization of the current pool of consented, donated
"There is a tremendous need for a solution to the global shortage of
organs available for transplant," said Dr. Waleed Hassanein, founder,
president and CEO of TransMedics, Inc. "The Organ Care System will play a
vital role in helping to increase the number of available organs by allowing
more time between organ donation and transplant, increasing the distance an
organ can travel, and improving the health of organs for better overall
In addition to increasing the number of transplantable organs and
decreasing the risk of post-surgical complications, this technology is also
aimed at providing significant cost benefits to the healthcare system. The
Organ Care System is designed to: reduce the period of time patients need to
be maintained on costly bridge therapies while waiting for a donor organ,
ensure more rapid recovery and reduced hospital stays following
transplantation, as well as reduce both the need for medical therapy to
treat complications and the need for re-transplantation.
The growing need for new transplant technologies
The number of people requiring a life-saving transplant continues to rise
faster than the number of available donors. Of the 89,000 people in the U.S.
currently waiting for a donor organ, only a third will receive a transplant,
while nearly 7,000 will die each year while waiting for an organ. This means
approximately 17 transplant candidates die each day while waiting to receive
a donor organ.
The situation is equally serious in Europe. For example, of the 12,000
people in Germany currently waiting for a donor organ, only a third will
receive a transplant. Nearly 1,000 transplant candidates die each year.
While there has been some progress in increasing donation rates in the last
year, the demand for donor organs is increasing as well. In the UK today,
there are 6,000 patients waiting for an organ transplant. However, fewer
than 3,000 transplants are carried out annually; thus the transplant list
continues to get longer. More than half of all hearts that have been
consented for donation still go unused. The limits of current cold
preservation methods contribute to this problem.