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 Paragonix Sherpa Pak Cardiac Transport System (CTS).
The CTS helps in static hypothermic preservation of hearts for up to four hours, during transportation and eventual transplantation into a recipient.
Paragonix Technologies chief medical officer 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 added.
Paragonix Technologies chief operating officer and co-founder Lisa Anderson said the company anticipates significant clinical interest for the Sherpa Pak CTS in the 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 added.