A Braintree-based biomedical technology company is changing how procured organs are transported from the donor to the recipient. Paragonix Technologies developed a new transport device that minimizes the susceptibility of donor hearts to damage caused by uneven temperatures in traditional coolers and extends the standard four-hour time constraint for organ transportation.
Paragonix is working with Boston area hospitals such as Massachusetts General Hospital on the device to improve the success of organ transplants.
Bill Edelman, chairman and CEO of Paragonix, said his company developed the SherpaPak Cardiac Transport System and other organ transportation technologies in order to ensure that donated organs are kept as “high quality as possible” while traveling to the patient receiving the transplant.
“Organ transport, the recovery of organs from donors and the maintenance of those organs while they’re in transport can be improved,” Edelman said. “… Our technology is designed to maintain the organ’s quality during the transit period, so nothing adverse can occur to it.”
The SherpaPak CTS is composed of a sterile, rigid canister filled with an organ preservation fluid, according to Edelman. The procured heart is suspended in the fluid and surrounded by packages of “phase change material” that can keep the temperature of the organ between an optimal 4 and 8 degrees Celsius.
This package is in turn placed within a shipping system that monitors temperature and protects the organ from vibrations and shocks, Edelman said. The shipping system can also display the temperature of the heart through a built-in display or via Bluetooth to a mobile app.
Edelman said a previous transportation method, which involved placing the heart in a bag of preservation fluid that is sandwiched between two layers of crushed ice and placed within a styrofoam cooler, could degrade the quality of the procured heart by making it too cold.
“The temperature requirements of the preservation fluid are not achieved, in fact, the temperatures actually go far below that to freezing,” Edelman said. “… The tissue becomes sometimes very stiff and frozen, and there could be freezing damage done to the organ, which is shown by how the organ will respond upon implantation.”
As for how the SherpaPak CTS improves upon the previous method, Edelman said the device ensures the heart does not come in contact with the cooling packs by suspending it in the preservation fluid. Additionally, the “phase change material” cooling packs are capable of holding temperature for many hours.
Edelman said that at a recent meeting of the International Society for Heart and Lung Transplantation, he heard reports from transplant centers using the SherpaPak CTS that the device may actually reduce costs associated with transplants and improve the organ transportation and patient recovery process.
“It seems to be allowing patients to be discharged more rapidly at one of the centers that have used it,” Edelman said. “And in another center, they spoke about using it for very, very long periods of recovery and transport. One case was at least seven hours in length, which is almost twice the duration of the existing methods.”
Besides the SherpaPak CTS, Edelman said Paragonix also offers a SherpaPerfusion Transport System in Europe, which takes the SherpaPak CTS and adds the ability to profuse oxygen into the preservation fluid. The company also developed a Kidney Transport System that functions similarly to the SherpaPak CTS but is smaller in the United States and Europe, he said.
Additionally, Edelman said Paragonix is in the process of developing a Lung Transport System, SherpaLung, which seeks to maintain optimal temperature while preventing air trapped in the lungs from expanding and damaging the organ due to pressure changes associated with air travel.
Paragonix has a long-standing relationship with Mass General, Edelman noted, as the hospital began performing clinical trials for the SherpaPak CTS in July 2018 and has continued to use the device since.
“Mass General was a natural partner for us to approach in the clinical evaluations of that device, and they were kind enough to do so,” Edelman said. “… As of yesterday, we heard a report from the lead surgeons that they’ve done about 24 of these procedures using our device, and they were very pleased with the outcome.”
Dr. David D’Alessandro, surgical director for Heart Transplantation and Ventricular Assist Devices at MGH, said in a Paragonix press release that the organ transportation progress has always been in need of improvement.
“The handling, packing and shipping of donor hearts is a critical part of the transplant process,” D’Alessandro said in the release published in September after the SherpaPak CTS completed a successful round of clinical trials. “We are always looking for new ways to improve the preservation and monitoring of donor hearts, with a goal of continually improving patient outcomes.”
Edelman said more hospitals have been trained to use the SherpaPak CTS and that Paragonix is now “really active” in each of the few hospitals in Boston that perform heart or lung transplants.
“We’re very excited to be in the Boston area developing this,” Edelman said, “and we work with a lot of the institutions in Boston, the academic institutions, and a lot of the medical device network which exists here. And it’s quite extensive, and we’re very appreciative to being in Boston.”
