The FDA granted two emergency authorizations to bl
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Posted On: 04/27/2020 1:03:39 PM
Re: someconcerns #171
The FDA granted two emergency authorizations to blood-filtering devices designed to assist the distressed immune and respiratory systems of patients with severe cases of COVID-19.
https://www.fiercebiotech.com/medtech/fda-gre...kid=944797
"FDA greenlights two blood-filtering systems for COVID-19
by
Conor Hale | Apr 27, 2020 7:25am
red blood cells
ALung's Hemolung removes carbon dioxide from the bloodstream, while Baxter's Oxiris device filters out cytokines and kidney toxins. (Pixabay)
The FDA granted two emergency authorizations to blood-filtering devices designed to assist the distressed immune and respiratory systems of patients with severe cases of COVID-19.
ALung Technologies’ Hemolung system is designed to treat patients suffering from acute respiratory failure by slowly removing excess carbon dioxide directly from the bloodstream.
The company said its dialysis-like machine has been treating COVID-19 patients under the agency’s previous, broader emergency use provisions—as well as in a clinical trial exploring its use in exacerbated chronic obstructive pulmonary disease—to help people avoid or reduce time on invasive mechanical ventilation.
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It has also been used in Europe, where it received a CE mark in 2013. In the U.K., the Hemolung device and carbon dioxide removal therapy was tested in acute respiratory distress syndrome.
Though not a full approval, the FDA said the device could potentially be used alongside a ventilator to help manage carbon dioxide and pH levels in the blood, according to ALung.
“With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as Ventilator Induced Lung Injury (VILI),” Chairman and CEO Peter DeComo said in a statement.
RELATED: FDA greenlights blood detox device to combat COVID-19's cytokine storms
The Oxiris filter set (Baxter)
At the same time, the FDA gave an emergency green light to Baxter’s Oxiris filter set to help reduce dangerous levels of inflammatory cytokines in patients undergoing intensive care and continuous renal replacement therapy.
Between 15% to 30% of severely ill COVID-19 patients may develop life-threatening kidney injuries, the company said, while others may see potentially deadly cytokine storms triggered by the immune system’s overreaction to the novel coronavirus. Early studies have shown about two-thirds of severe cases may show additional organ dysfunction syndromes, which could be caused by high levels of cytokines in the bloodstream.
The Oxiris system removes these cytokines—as well as additional renal toxins simultaneously, without additional filters or adsorbers—before returning the cleaned blood back to the patient. It has been validated for use with Baxter's PrisMax and Prismaflex systems, the latter of which launched in the U.S. last year"
https://www.fiercebiotech.com/medtech/fda-gre...kid=944797
"FDA greenlights two blood-filtering systems for COVID-19
by
Conor Hale | Apr 27, 2020 7:25am
red blood cells
ALung's Hemolung removes carbon dioxide from the bloodstream, while Baxter's Oxiris device filters out cytokines and kidney toxins. (Pixabay)
The FDA granted two emergency authorizations to blood-filtering devices designed to assist the distressed immune and respiratory systems of patients with severe cases of COVID-19.
ALung Technologies’ Hemolung system is designed to treat patients suffering from acute respiratory failure by slowly removing excess carbon dioxide directly from the bloodstream.
The company said its dialysis-like machine has been treating COVID-19 patients under the agency’s previous, broader emergency use provisions—as well as in a clinical trial exploring its use in exacerbated chronic obstructive pulmonary disease—to help people avoid or reduce time on invasive mechanical ventilation.
Virtual Event
Virtual Clinical Trials Online
This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.
Register Today!
It has also been used in Europe, where it received a CE mark in 2013. In the U.K., the Hemolung device and carbon dioxide removal therapy was tested in acute respiratory distress syndrome.
Though not a full approval, the FDA said the device could potentially be used alongside a ventilator to help manage carbon dioxide and pH levels in the blood, according to ALung.
“With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as Ventilator Induced Lung Injury (VILI),” Chairman and CEO Peter DeComo said in a statement.
RELATED: FDA greenlights blood detox device to combat COVID-19's cytokine storms
The Oxiris filter set (Baxter)
At the same time, the FDA gave an emergency green light to Baxter’s Oxiris filter set to help reduce dangerous levels of inflammatory cytokines in patients undergoing intensive care and continuous renal replacement therapy.
Between 15% to 30% of severely ill COVID-19 patients may develop life-threatening kidney injuries, the company said, while others may see potentially deadly cytokine storms triggered by the immune system’s overreaction to the novel coronavirus. Early studies have shown about two-thirds of severe cases may show additional organ dysfunction syndromes, which could be caused by high levels of cytokines in the bloodstream.
The Oxiris system removes these cytokines—as well as additional renal toxins simultaneously, without additional filters or adsorbers—before returning the cleaned blood back to the patient. It has been validated for use with Baxter's PrisMax and Prismaflex systems, the latter of which launched in the U.S. last year"
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