Categories: News

XVIVO’s Kidney Assist Transport Receives 510(k) Clearance by US FDA, Which Is XVIVO’s First Regulatory Cleared Product for Abdominal Transplantation in the US

GOTHENBURG, SWEDEN / ACCESSWIRE / January 21, 2022 / XVIVO Perfusion AB (STO:XVIVO)(LSE:0RKL)(FRA:3XV) Today XVIVO proudly announces that the US Food & Drug Administration (FDA) has granted clearance for Kidney Assist Transport. Organ donors and organ recipients are rarely at the same hospital, and therefore organs need to be transported in a safe and reliable manner. The device is a transportable organ perfusion system that allows for continuous oxygenated perfusion for up to 24 hours and has been shown to improve preservation compared to cold storage./p>

According to the World Health Organization (WHO) kidney disease is the world’s 10th most common cause of death. Patients suffering from end-stage kidney disease need regular dialysis or a kidney transplant to survive. Transplantation is the preferred treatment as it improves the patient’s quality of life and survival. Kidney transplant is also a far more cost-effective treatment option than dialysis. Today the US is the largest market with approximately 18,700 kidney transplants from deceased donors in 2021, and there are currently more than 90,000 patients on the waitlist for a new kidney. The need for organs available for transplantation far exceeds the supply.
A recent article in the scientific journal The Lancet suggests that hypothermic machine perfusion with oxygen using Kidney Assist Transport can reduce severe complications, additional diagnostic procedures, hospital readmission and cost for chronic dialysis1.

“Already before launch there has been a huge interest for Kidney Assist Transport, and we as an organization are thrilled to take this unique device to market. We will initiate the launch regionally and continue to scale up throughout the year,” says Managing Director North America Fredrik Dalborg.

“We are now establishing a strong commercial presence in the US within abdominal transplantation, with a firm focus on kidneys. Our strategy is to become the global leader within abdominal where Kidney Assist Transport is a true enabler. I feel honored that we today can launch this fantastic device after years of dedicated development and several clinical trials. Kidney Assist Transport will make more kidneys available for transplantation”, says Dag Andersson, CEO of XVIVO.

January 21, 2022
Gothenburg
Dag Andersson, CEO
XVIVO Perfusion AB (publ)

[1] Johmanns I, et al. Oxygenated versus standard cold perfusion preservation
in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. The Lancet. November 2020;396 (10263):1653-1662.

SOURCE: XVIVO Perfusion AB

View source version on accesswire.com:
https://www.accesswire.com/685030/XVIVOs-Kidney-Assist-Transport-Receives-510k-Clearance-by-US-FDA-Which-Is-XVIVOs-First-Regulatory-Cleared-Product-for-Abdominal-Transplantation-in-the-US

Staff

Recent Posts

Saprea Recognizes 2024 Global Milestones in Supporting Child Sexual Abuse Survivors Through Healing Resources

Lehi, Utah--(Newsfile Corp. - December 23, 2024) - As Saprea reflects on the accomplishments of…

3 hours ago

THE STATE OF GLOBAL OPTIMISM REVEALED BY LG IN NEW SURVEY

Company Unveils the Biggest Topics of Global Optimism: Entertainment, AI and Healthcare. SEOUL, South Korea,…

3 hours ago

Daily Fit Notes Rolls Out Affordable Fitness Solutions for the Modern Lifestyle

Daily Fit Notes, founded by Justin Brey in New York, launches a text-based subscription fitness…

2 days ago

WillowWood Rebrand by DD.NYC Wins Gold Anthem Award for Product and Innovation in 2024 Rebrand

MT. STERLING, Ohio, Dec. 20, 2024 /PRNewswire/ -- WillowWood, a global leader in prosthetic solutions,…

2 days ago