XVIVO PERFUSION SYSTEM (XPS™) WITH STEEN SOLUTION™ PERFUSATE – P180014
INDICATION
The XVIVO Perfusion System (XPS™) With STEEN Solution™ Perfusate is indicated for the flushing and temporary continuous warm machine perfusion of initially unacceptable donor lungs during which time the function of the lungs outside the body can be reassessed for transplantation.
IMPORTANT SAFETY INFORMATION
Potential Adverse Events
The XPS™ With STEEN Solution™ Perfusate device is indicated for use only on donor lungs removed from the donor body. There is no direct patient contact with this device; however, the device has a direct contact with the lungs that are subsequently transplanted into you. The donor lung quality after preservation has a direct effect on organ function and survival. The potential for infection and physical trauma, due to the handling and placing of a tube in the lung airway and connecting blood vessels, may lead to complications after transplantation (e.g., infection, pneumonia, pneumothorax (collapsed lung)/hemothorax (bleeding into the chest cavity), etc.).
Patients receiving a lung treated with the XPS™ System with STEEN Solution™ Perfusate device may experience the following side effects including those experienced with any lung transplant:
- Death
- Kidney failure or dysfunction
- Respiratory dysfunction/infection
- Primary graft dysfunction
- Acute rejection
- Cardiac arrhythmias
- Bronchiolitis Obliterans Syndrome (BOS) (obstructive Lung Disease Of The Small Airways)
- Bronchiole stenosis/Dehiscence (restricted airways)
- Post-operative Bleeding/hemorrhage
- Re-transplantation
Prescription Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. See the Patient Labeling for further detailed information. For further information, please call (303) 395-9171 and/or consult XVIVO’s website at www.xvivoperfusion.com.
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XVIVO PERFUSION SYSTEM (XPS™) WITH STEEN SOLUTION™ PERFUSATE – P180014
INDICATION
The XVIVO Perfusion System (XPS™) With STEEN Solution™ Perfusate is indicated for the flushing and temporary continuous warm machine perfusion of initially unacceptable donor lungs during which time the function of the lungs outside the body can be reassessed for transplantation.
IMPORTANT SAFETY INFORMATION
Potential Adverse Events
The XPS™ With STEEN Solution™ Perfusate device is indicated for use only on donor lungs removed from the donor body. There is no direct patient contact with this device; however, the device has a direct contact with the lungs that are subsequently transplanted into you. The donor lung quality after preservation has a direct effect on organ function and survival. The potential for infection and physical trauma, due to the handling and placing of a tube in the lung airway and connecting blood vessels, may lead to complications after transplantation (e.g., infection, pneumonia, pneumothorax (collapsed lung)/hemothorax (bleeding into the chest cavity), etc.).
Patients receiving a lung treated with the XPS™ System with STEEN Solution™ Perfusate device may experience the following side effects including those experienced with any lung transplant:
- Death
- Kidney failure or dysfunction
- Respiratory dysfunction/infection
- Primary graft dysfunction
- Acute rejection
- Cardiac arrhythmias
- Bronchiolitis Obliterans Syndrome (BOS) (obstructive Lung Disease Of The Small Airways)
- Bronchiole stenosis/Dehiscence (restricted airways)
- Post-operative Bleeding/hemorrhage
- Re-transplantation
Prescription Information
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. See the Patient Labeling for further detailed information. For further information, please call (303) 395-9171 and/or consult XVIVO’s website at www.xvivoperfusion.com.
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