Paragonix’s Kidney Transport Device Gets FDA OK

Paragonix Technologies said Wednesday that it received FDA 510(k) clearance for its Sherpa Pak kidney transport system for hypothermically preserving kidneys during transportation and subsequent transplantation into a recipient.

Conventional ice-packing methods can result in undesirable and potentially injury-inducing temperatures of zero degrees Celsius and below within hours of organ storage, the Braintree, Mass., company notes. Sherpa Pak uses cold storage solutions compatible with the kidney to ensure an optimal donor organ storage temperature of 4 degrees to 8 degrees Celsius over 24 hours, Paragonix adds.

A temperature display and timer monitor the real-time organ storage temperature and display the time elapsed during transport, the company notes.

Paragonix Chairman Bill Edelman told Device Daily Bulletin that the company expects to release the Sherpa Pak system in the U.S. within the next couple of fiscal quarters. He added that while the device is only authorized in the U.S., the company is receiving “very positive” reactions from surgeons around the world, asking when Sherpa Pak will be available elsewhere.

Paragonix currently is assembling materials for a CE Mark design dossier and will announce later when it plans to file a submission, Edelman said. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.