Paragonix Cleared to Sell Sherpa Pak Systems With Organ Preservation Solutions
Braintree, Mass.-based Paragonix Technologies said Tuesday that it has received FDA clearance to combine and distribute its Sherpa Pak organ transport systems with any FDA-cleared organ preservation solution.
The convenient format will simplify hospital purchasing and organ transplant team logistics, say Paragonix Chairman and CEO Bill Edelman. Hospitals really “appreciate the ability to get everything all at once,” he tells Device Daily Bulletin.
Paragonix declined to identify the solutions it will pair with the Sherpa Pak systems, but said they are currently available in the U.S. market.
The company received 510(k) clearance for the stand-alone Sherpa Pak Cardiac Transport System in February 2013 and for the Sherpa Pak Kidney Transport System this past May. The fully disposable systems eliminate problems associated with maintenance, device transport and contamination, according to Paragonix, providing a safe and consistent method for cold short-term storage and transport of donor organs for implantation. — Kellen Owings
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