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 organs.

"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 outcomes."

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.

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