By Susan Comninos
NEW YORK (Reuters Health) – TransMedics' warm-blood preservation machine has shown promise in supporting life function of human organs bound for transplant, the US firm told Reuters Health on Monday.
A kidney placed in the machine over the weekend was kept alive and working for almost 24 hours, according to researchers at the University of Chicago Hospitals and TransMedics President and CEO Dr. Waleed Hassanein. The kidney remained viable until it was disconnected from the machine for study, the researchers said.
Dubbed the Portable Organ System, TransMedics' POS is designed to maintain the viability of all solid organs, Dr. Hassanein said in a phone interview on Monday.
Its use in preserving various organs is now being tested at nine hospitals in Europe and North America, including at Britain's Harefield Hospital; Mt. Sinai, Brigham and Women's Hospital, Cleveland Clinic, UCLA; and the University of Alberta-Edmonton, he noted.
However, only the Chicago test site has yet to yield clinical results.
The POS is designed to simulate a warm human body, keeping organs functioning normally for up to 48 hours after removal from a donor, Dr. Hassanein told Reuters Health. That time span improves upon the current preservation of organs via the "ice method," which is viable for only 4 hours to 36 hours, and can involve cell damage, he said.
For highly perishable organs like the heart and liver, which can be preserved on ice for only 4 hours to 12 hours, the POS may be able to maintain the organ for transplant for up to 24 hours to 30 hours, Dr. Hassanein claimed. That extra time would allow organs for transplant to be procured from greater distances, he noted.
Currently, many organs that might be harvested for transplant are "wasted," as they cannot be immediately packed in ice or studied by a researcher prior to implant, he said. Further, surgeons will not consider organs from donors who die in accidents, of gunshot wounds, or from trauma–so called "non-heart-beating" donors, Dr. Hassanein said.
While these represent a "huge pool" of potential implants, there is no marketed technology that would allow a transplant surgeon to fully evaluate such organs "prior to making somebody else's life dependent on it," the executive said.
Some of these organs could be usable if put in the POS, he maintains. Asked how much time could elapse between clinical death and POS hook up, Dr. Hassanein answered, "15 minutes to 30 minutes for heart and lung, and up to an hour for kidney and liver."
The company is continuing its research to determine how long an organ can survive without damage outside a living environment, he noted.
The firm intends to submit the device for US regulatory clearance this fall and hopes to launch the machine on the domestic market in 2002, he said. Initially, TransMedics will pursue the kidney preservation indication, Dr. Hassanein said, adding that the firm aims to file for EU and Canadian regulatory clearance of the POS in mid-2002.
If the POS gains regulatory clearance, it will be the firm's first launched product. Dr. Hassanein, who also founded the 3-year-old company, would not give an estimate of the device's possible cost.
TransMedics, based in Woburn, Massachusetts, is currently supported through venture capital backing.