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- Paragonix Technologies has received EU Medical Device Regulation approval for five organ preservation devices, confirming compliance with Europe's most stringent quality standards for medical devices. - The approved devices include SherpaPak for heart preservation, BAROguard and LUNGguard for lungs, PancreasPak for pancreas, and LIVERguard for liver preservation, all designed to enhance organ transport safety and viability. - Clinical studies have demonstrated that Paragonix cardiothoracic devices reduce post-transplant complications and safely extend ischemic times, with over 10,000 transplant cases globally since 2018.
- Paragonix Technologies' KidneyVault, a portable hypothermic perfusion system, has received FDA 510(k) clearance to improve donor kidney preservation during transport. - The KidneyVault system integrates digital monitoring with perfusion technology, aiming to expand the donor kidney pool and enhance organ quality for transplantation. - With over 106,000 patients on the U.S. transplant waitlist, and 86% needing a kidney, KidneyVault addresses the critical need for improved organ preservation. - Paragonix is now the only company with U.S. regulatory clearance for preservation technologies across all five solid organs used in transplant procedures.
- Paragonix Technologies has received FDA 510(k) clearance for its KidneyVault System, a portable hypothermic perfusion device for donor kidney preservation. - The KidneyVault integrates digital monitoring with perfusion technology, aiming to improve kidney preservation during transport and expand the donor pool. - This clearance makes Paragonix the only company with U.S. regulatory clearances for all five solid organs used in transplant procedures. - The KidneyVault addresses the critical need for a user-friendly device to optimize kidney preservation, potentially improving outcomes for patients on the transplant waitlist.
- Paragonix Technologies' Kidney Vault has received FDA approval, enhancing the preservation and transportation of kidneys for transplantation. - The device maintains a consistent hypothermic environment, aiming to improve organ quality and patient outcomes following kidney transplants. - This FDA nod marks a significant advancement in organ preservation technology, potentially increasing the viability of donor kidneys. - The Kidney Vault addresses critical needs in organ transplantation by providing a standardized and controlled method for kidney transport.
