Paragonix Technologies has received clearance for its second premarket notification (510(k)) from 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 for up to four hours, during transportation and eventual transplantation into a recipient, using appropriate cold storage solutions.
The second 510(k) pre-market notification application was filed on 18 November 2013 with the FDA for the Paragonix Sherpa CTS.
The current cleared indication states that while using the device, donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with the International Society Of Heart and Lung Transplantation (ISHLT's) guidelines in the interest of the heart transplant patient.
ISHLT limits the projected ischemic time to four hours, which restricts the distance a donor heart can be transported.
The Sherpa Pak CTS is intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for implantation.
It is designed for transport of hearts within the time frame currently considered as routine medical practice.
Paragonix Technologies state that the Sherpa Pak CTS is capable of maintaining cold storage solution temperature between 4°C and 8°C for up to 12 hours.
Paragonix COO and co-founder Dr Lisa Anderson said: "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 pre-market clearances while we continue our development of several additional Sherpa CTS products."
On 17 December 2013, Paragonix announced filing of a 510(k) pre-market notification application with the FDA for the Paragonix Sherpa Pak Transporter.
In February 2013, the company obtained a 510(k) clearance for the Paragonix Sherpa CTS.
Currently under development, the Sherpa Perfusion CTS combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts.
Paragonix has exclusively licensed University of Texas Health Science Center San Antonio intellectual property from the Office of Technology Transfer and Commercialization.