This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name:Â XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
HDE Applicant:Â XVIVO Perfusion, Inc.
Address:Â 3666 S Inca Street, Englewood, COÂ 80110
Approval Date:Â August 12, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/H120003a.pdf
What is it? The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate preserves donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function.
The XPS System consists of hardware, software, STEEN solution, tubing sets, and an organ chamber. The XPS System houses the organ for preservation and perfuses it with a preservation solution, during which time the lungs can be assessed by the transplant surgeon. The STEEN Solution temporarily maintains the isolated lungs after removal from the donor.
How does it work? The XPS System warms the donor lungs to near normal body temperature. It continuously flushes the lung tissue with the STEEN Solution which preserves the lungs and removes waste products. The XPS System also ventilates the lungs which provides oxygen to the cells and makes it possible for the transplant team to examine the airways with a bronchoscope.Â
The XPS System with STEEN Solution Perfusate is used only with donor lungs that have been removed. There is no direct patient contact with this device; however, the device has a direct contact with the lungs which are later transplanted into the recipients.
Donor lungs can stay in the machine for up to four hours. During this time the transplant team examines the lungs and evaluates their function outside the body. If the lungs meet certain criteria and pass the transplant surgeon’s examination, they are transplanted into a recipient.
When is it used? The XPS System with STEEN Solution Perfusate is used to flush and preserve initially unacceptable donor lungs after removal and prior to transplantation, if they are found suitable for transplantation after reassessment.
What will it accomplish? The XPS System with STEEN Solution Perfusate may:Â
- Increase the donor pool by allowing the safe transplantation of initially unacceptable donor lungs.
- Resolve lung problems caused by excess fluid in the tissue (such as electrolyte balance, pressure in the tissues, and temperature).
- Dilute and filter away any remaining donor blood and/or clots still in the lungs.
- Allow for re-expansion of collapsed lung areas.
- Allow time to assess and clean/suction bronchial secretions.
- Help pump the STEEN Solution Perfusate into the lungs’ tiny blood vessels.
The donor lung quality and functionality after preservation has a direct effect on the transplant function and survival. The potential for contamination and trauma, due to manipulating and inserting a tube into the lung airway and blood vessels, may lead to complications after transplantation (such as pneumonia and other infections, a collapsed lung, or blood in the membranes of the lungs).
Patients receiving a lung treated with the XPS System with STEEN Solution Perfusate may experience adverse events including the following that may occur with any lung transplant.
- Death
- Renal failure or dysfunction
- Respiratory dysfunction/infection
- Primary graft dysfunction /lung not responding
- Acute rejection
- Arrhythmias
- Bronchiolitis Obliterans Syndrome (BOS)
- Airway complications including infection, narrowing of air passages, or rupture of the surgical wound.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Probable Benefit and labeling are available online.
- FDA News Release