The Sherpa Cardiac Transport System. Photo taken from the company’s website.
Paragonix Technologies Inc., a Braintree-based medical device company focused on organ preservation technology, said that it has successfully completed filing of a Pre-Marketing Notification Application with the US Food and Drug Administration for a product designed to transport kidneys that will be used in transplant operations.
The product, known as Sherpa Pak Transporter, is designed for the static hypothermic preservation of kidneys during transportation and eventual transplantation into a recipient, the company said in a press release. The Pre-Marketing Notification Application is sometimes referred to as a 510(k) pre-market application.
“This 510(k) pre-market application, when cleared by FDA, will expand our product portfolio of organ preservation technologies,” Lisa Anderson, chief operating officer and cofounder of Paragonix, said in a statement. “Following excellent market reaction to our Sherpa Pak Cardiac Transport System, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak Transporter will be cleared for commercial distribution.”
Paragonix is also working on the Sherpa Cardiac Transport System, a single-use organ preservation device designed to improve donor organ quality and extend donor organ preservation times. The Sherpa 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. Ischemic time is the elapsed time from heart donation to recipient implantation.