Paragonix Technologies, Inc. has received clearance for its second FDA 510(k) clearance with the Paragonix Sherpa Pak™ Cardiac Transport System(CTS), which is designed to provide a safe, consistent method for cold ischemic storage and transport of donor hearts within the current guideline timeframe of 4 hours.
Background
This is undoubtedly the first time we’ve discussed donor heart storage systems on our pages. Currently the availability of cardiac transplantation is governed by the “ischemic time”, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (“ISHLT”) guidelines for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours, limiting the distance available to transport a donor heart. While Paragonix is developing a Cardiac Transport System tagged Sherpa Perfusion™, with the goal of extending ischemic time to 12 hours, its Sherpa Pak™ CTS is merely intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for implantation within the time frame currently considered as routine medical practice, ie 4 hours.
As described in the product’s labeling, following assembly, the Sherpa Pak CTS™ is capable of maintaining cold storage solution temperature between 4° and 8° C for up to 12 hours. The current cleared indication further states that when 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 accepted clinical guidelines and in the best medical interest of the intended recipient”.
Company comments
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are thrilled to have received clearance of a second premarket notification from 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 pre-market clearances while we continue our development of several additional Sherpa CTS products.”
Leonard Golding, MD, Chief Medical Officer at Paragonix, commented, “Clearance of a second Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for our Paragonix Sherpa Pak™ CTS, is an important step towards introducing this technology into clinical practice. The Sherpa Pak™ CTS will enable standardization of donor heart preservation and transportation.”
Source: Paragonix, inc., Business Wire
published: February 25, 2014 in: Approval/Clearance, Cardio