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  1. Device Approvals, Denials and Clearances

XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014

XVIVO Perfusion System (XPS™) with STEEN Solution

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 Effectiveness Data and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate
PMA Applicant: XVIVO Perfusion, Inc.
Address: 3666 S Inca Street, Englewood, CO 80110
Approval Date: April 26, 2019
Approval Letter: Approval Order

What is it?

The XVIVO Perfusion System (XPS™) with STEEN Solution™ is intended to be used on donor lungs prior to transplantation in patients with end-stage lung disease.

The XPS™ with STEEN Solution™ consists of the XPS™ Perfusion Cart Hardware, fluid path and non-fluid path disposables, XPS™ Cart Software, and STEEN Solution™. The XPS™ System is responsible for housing the organ for preservation, providing an environment close to body temperature, and perfusing the organ with the STEEN Solution™. The STEEN Solution™ is a clear, sterile, non-pyrogenic (does not cause fever), non-toxic physiological salt solution containing human serum albumin (HSA) and dextran 40 that is designed for use as a temporary, continuous machine perfusion solution for assessment of isolated lungs after removal from the donor.

How does it work?

The XPS™ System warms the donor lungs to near normal body temperature and 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 oxygenates the cells and makes it possible for the transplant team to examine the airways of the lungs with a bronchoscope. Donor lungs can stay in the machine for up to five (5) hours; during this time the transplant team can examine the lungs and evaluate their function. If the lungs meet certain functionality criteria, and pass the transplant surgeon’s examination, they aretransplanted into a recipient.

When is it used?

The XPS™ System with STEEN Solution™ Perfusate is used only on previously unaccepted donor lungs that will be transplanted into a patient with end-stage lung disease.

What will it accomplish?

The use of XPS™ System with STEEN Solution™ Perfusate may increase the donor pool by allowing the safe transplantation of initially unacceptable donor lungs. This includes:

  • Allowing time for the lung(s) to re-establish their normal condition in an optimized environment;
  • Restoring physiologic problems caused by neurogenic pulmonary edema (e.g., electrolytic balance, colloid-osmotic pressure, and temperature);
  • Diluting and filtering away any remaining donor blood and/or clots still in the lung(s);
  • Allowing for re-expansion of atelectatic lung areas;
  • Allowing time to assess and clean/suction bronchial secretions; and
  • Facilitating perfusion of the pulmonary micro-vasculature with the use of dextran in the STEEN Solution™ Perfusate.

When should it not be used?

There are currently no known reasons to not use the XPS™ System with STEEN Solution™ Perfusate on previously unaccepted lungs for transplantation into patients.

Additional information (including warnings, precautions and adverse events):