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XVIVO Perfusion

FDA clears Xvivo’s lung transplant perfusion system

April 29, 2019 By Fink Densford

The FDA today granted premarket approval to Xvivo Perfusion for its Xvivo Perfusion system with Steen solution perfusate intended to temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplantation procedures. The system is designed for use with lungs initially thought to be unacceptable for transplant, and allows a transplant team to perform […]

Filed Under: Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Respiratory, Transplants Tagged With: XVIVO Perfusion

U.S. trial test machine that ‘reconditions’ lungs outside body

May 18, 2016 By MassDevice

(Reuters) – A machine that ‘reconditions’ a donor’s lungs outside the body before being transplanted into a recipient is undergoing tests in the United States in the hope that it can radically improve survival rates for people with chronic respiratory diseases. The XPS, manufactured by Swedish company XVIVO Perfusion , is in clinical trials at […]

Filed Under: Respiratory Tagged With: XVIVO Perfusion

XVIVO Perfusion wins FDA approval for donor lung transport system

August 13, 2014 By Arezu Sarvestani Leave a Comment

XVIVO Perfusion wins FDA approval for donor lung transport system

The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

August 13, 2014 By MassDevice Contributors Network Leave a Comment

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, Press Release, XVIVO Perfusion

FDA sets a date to review XVIVO’s lung perfusion system

February 14, 2014 By Arezu Sarvestani Leave a Comment

FDA sets a date to review XVIVO's perfusion system

Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.

XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

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