Paragonix Technologies, Inc. today announced that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System(CTS). The Sherpa Pak CTS is indicated for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart. The current pre-market notification application intends to further identify user indications for the static hypothermic preservation of hearts during transportation.
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, "We are thrilled to have filed the second Pre-Marketing Notification Application (510(k)) with FDA for the Sherpa Pak™ CTS. Following excellent market reaction to our first 510(k) cleared product, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak™ CTS will be cleared for commercial distribution. This is the second in a series of regulatory applications while we continue our development of several additional Sherpa CTS products."
Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American Society for Artificial Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability."