Sam Brusco, Associate Editor01.25.22
XVIVO was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its Kidney Assist Transport, a transportable organ perfusion system that provides continuous oxygenated perfusion for up to 24 hours. The device has been shown to improve preservation compared to cold storage.
The U.S. is currently the largest market for kidney transplants with about 18,700 from deceased donors in 2021. There are over 90,000 patients on the waitlist for a new kidney today.
A recent The Lancet article1 suggested Kidney Assist Transport’s hypothermic machine perfusion with oxygen can reduce severe complications, further diagnostic procedures, hospital readmission, and cost for chronic dialysis.
“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,” Managing Director North America Fredrik Dalborg told the press. “We will initiate the launch regionally and continue to scale up throughout the year.”
“We are now establishing a strong commercial presence in the U.S. within abdominal transplantation, with a firm focus on kidneys,” added Dag Andersson, CEO of XVIVO. “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.”
Reference
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.
The U.S. is currently the largest market for kidney transplants with about 18,700 from deceased donors in 2021. There are over 90,000 patients on the waitlist for a new kidney today.
A recent The Lancet article1 suggested Kidney Assist Transport’s hypothermic machine perfusion with oxygen can reduce severe complications, further diagnostic procedures, hospital readmission, and cost for chronic dialysis.
“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,” Managing Director North America Fredrik Dalborg told the press. “We will initiate the launch regionally and continue to scale up throughout the year.”
“We are now establishing a strong commercial presence in the U.S. within abdominal transplantation, with a firm focus on kidneys,” added Dag Andersson, CEO of XVIVO. “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.”
Reference
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.