Paragonix Technologies, a medical device company, has announced the filing of a 510(k) pre-marketing notification application with the US Food and Drug Administration (FDA) for its Sherpa Pak transporter.
Paragonix Technologies has designed the Sherpa Pak transporter for the static hypothermic preservation of kidneys during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the kidney.
The Sherpa Pak transporter combines innovative cooling technology with a safe, consistent method for cold ischemic storage and transport of donor kidneys to recipients for implantation.
Paragonix Technologies COO and co-founder Dr Lisa Anderson noted the company is excited to have filed the 510(k) pre-marketing notification application with FDA for the Sherpa Pak transporter.
"This 510(k) pre-market application, when cleared by FDA, will expand our product portfolio of organ preservation technologies. 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.
"This is the third in a series of regulatory applications while we continue our development of several additional Sherpa products," Dr Anderson added.
Paragonix Sherpa technology is designed to be used in conjunction with any of the currently available organ preservation solutions. Sherpa eliminates problems associated with maintenance, device transport and contamination.