Paragonix Technologies, Inc. today announced that it has successfully completed filing of a 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.
Lisa M. Anderson, PhD, President, Chief Operating Officer and Co-Founder for Paragonix commented, "We are thrilled to have reached the milestone of filing the Pre-Marketing Notification Application (510(k)) with FDA for the Sherpa Pak™ CTS. 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 first in a series of regulatory applications while we continue our development of several additional Sherpa CTS products."
Steven S. L. Tsui, MA, MD, FRCS, Director of the Transplant & Mechanical Circulatory Support program at Papworth Hospital, Cambridge, United Kingdom, commented, "The availability of donor hearts has been historically 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. 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. I look forward to seeing the Sherpa product line on the market."
Paragonix Technologies, Inc.