The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification (PMA) application of Paragonix Technologies’ single-use organ preservation device.
The Paragonix Sherpa Pak Cardiac Transport System (CTS) is designed for the static hypothermic preservation of hearts for up to four hours, during transportation and eventual transplantation into a recipient, using appropriate cold storage solutions.
The International Society Of Heart and Lung Transplantation’s guidlines for the care of heart transplant recipients limit the projected ischemic time to four hours, which restricts the distance a donor heart can be transported.
Paragonix Technologies chief medical officer Dr Leonard Golding said the availability of donor hearts has been impeded by both organ preservation limitations and the time required from donation to recipient implantation.
"The Sherpa technology now being developed by Paragonix holds the promise of addressing both critical needs," Golding said.
"With an aging population world-wide and an increasing incidence of congestive heart failure leading inexorably to heart transplantation, the clinical community will look to solutions that increase organ availability and organ quality."
Paragonix Technologies chief operating officer and co-founder Dr Lisa Anderson said the company anticipates significant clinical interest for the Sherpa Pak CTS in markets where the product will be cleared for commercial distribution.
"This is the first in a series of regulatory applications while we continue our development of several additional Sherpa CTS products," Anderson said.