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Important Safety Information for XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate – P180014

Warnings and Precautions
General Warnings

The safety and effectiveness of the XPS™ System with STEEN Solution™ Perfusate device were not evaluated with ideal criteria donor lungs.

Risk for Contamination and Mechanical Trauma

The degree of organ manipulation required for airway and vascular cannulation carries the potential for contamination and mechanical trauma of the donor lungs. Even though not contraindicated, it is not recommended to use an organ with evident signs of mechanical trauma or major contamination.

XPS™ Machine Operation-Related Warnings

See Warnings and Precautions in the XPS™ System Instructions for Use manual.

STEEN Solution™ Warnings

The responsibility to adhere to the approved labeling and Instructions for Use rests with the user. The Instructions for Use are only provided as suggestions for procedure. The user must, on the basis of his or her medical training and experience, evaluate the suitability of this procedure. When administered systemically, human serum albumin and Dextran have been associated with rare allergic reactions. However, no such reactions have been reported with either of these substances when used for ex vivo lung preservation.

XVIVO Lung Cannula Set™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Organ Chamber™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Disposable Lung Circuit™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Disposable Lung Kit™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XPS™ Machine Operation-Related Precautions

See Warnings and Precautions in the XPS™ System Instructions for Use manual.

STEEN Solution™ Precautions

STEEN Solution™ is intended for single use only and MAY NOT BE REUSED. Any leftover solution must be disposed of after the procedure.

Do not use STEEN Solution™ if the solution is not clear, the bottle is damaged, the flip-tear seal has been tampered with, or if the “use by” date has expired. Transplant Suitability Post-Ex Vivo Lung Perfusion (EVLP) The responsibility for correct clinical use and interpretation of the lung function evaluations during EVLP in determining transplant suitability resides exclusively with the transplant surgeon.

Like in any other clinical decision, all available data should be taken into consideration when determining the suitability of an organ for transplantation; that is, the transplant surgeon is clinically satisfied with the lung evaluation. This criterion should take priority, since the transplant surgeon is the ultimate responsible person for safely transplanting EVLP lungs. The use of the EVLP lung physiologic evaluations in determining transplantability (e.g., EVLP transplantability criteria) has been evaluated in the clinical studies, including the NOVEL trial (see summary of NOVEL study below). Validation has not occurred as to whether the parameters are adequate as surrogates for in vivo performance.

The use of ex-vivo perfusion/ventilation discrete parameters on their own to determine transplant suitability according to the two sets of transplantability criteria used in the NOVEL and NOVEL EXTENSION respectively have not been validated. Clinicians should exercise discretion when using these criteria as the main decision-making tool for transplantability and instead utilize the perfusion/ventilation trends coupled with EVLP x-rays and bronchoscopies and their clinical expertise to make decisions on transplant suitability. Two different transplant suitability criteria (NOVEL: 2 consecutive delta PaO2s ≥ 350 vs NOVEL Extension: 2 non-consecutive delta PaO2s ≥ 350 OR 1 absolute PaO2 > 400) have been used in the NOVEL and NOVEL EXTENSION respectively, and neither of these criteria have been validated. The transplant suitability criteria between the NOVEL and NOVEL Extension studies have shown no difference in survival and/or incidence of Primary Graft Dysfunction (PGD).

Potential Adverse Events

The XPS™ with STEEN Solution™ Perfusate device is indicated for use only on previously unacceptable excised donor lungs in an ex vivo setting. There is no direct patient contact when this device is used as labeled; however, the device has a direct contact with the lungs that are subsequently transplanted into the recipients. The donor lung quality and optimization after preservation have direct effects on allograft function and survival.

The potential for contamination and mechanical trauma, due to the manipulation and cannulation of the lung airway and vascular structures, may lead to complications after transplantation.

Patients receiving a lung treated with the XPS™ System with STEEN Solution™ Perfusate device may experience adverse events including those experienced with any lung transplant.

Indication

Indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.

Prescription Information

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. See the Physician Labeling for further detailed information. For further information, please call (303) 395-9171 and/or consult XVIVO’s website at www.xvivoperfusion.com.

XVIVOISIhcpMar20

Click to expand

Important Safety Information for XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate – P180014

Warnings and Precautions
General Warnings

The safety and effectiveness of the XPS™ System with STEEN Solution™ Perfusate device were not evaluated with ideal criteria donor lungs.

Risk for Contamination and Mechanical Trauma

The degree of organ manipulation required for airway and vascular cannulation carries the potential for contamination and mechanical trauma of the donor lungs. Even though not contraindicated, it is not recommended to use an organ with evident signs of mechanical trauma or major contamination.

XPS™ Machine Operation-Related Warnings

See Warnings and Precautions in the XPS™ System Instructions for Use manual.

STEEN Solution™ Warnings

The responsibility to adhere to the approved labeling and Instructions for Use rests with the user. The Instructions for Use are only provided as suggestions for procedure. The user must, on the basis of his or her medical training and experience, evaluate the suitability of this procedure. When administered systemically, human serum albumin and Dextran have been associated with rare allergic reactions. However, no such reactions have been reported with either of these substances when used for ex vivo lung preservation.

XVIVO Lung Cannula Set™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Organ Chamber™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Disposable Lung Circuit™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XVIVO Disposable Lung Kit™ Precautions

Store at room temperature. Use only undamaged/unopened containers. Single Use Only.

XPS™ Machine Operation-Related Precautions

See Warnings and Precautions in the XPS™ System Instructions for Use manual.

STEEN Solution™ Precautions

STEEN Solution™ is intended for single use only and MAY NOT BE REUSED. Any leftover solution must be disposed of after the procedure.

Do not use STEEN Solution™ if the solution is not clear, the bottle is damaged, the flip-tear seal has been tampered with, or if the “use by” date has expired. Transplant Suitability Post-Ex Vivo Lung Perfusion (EVLP) The responsibility for correct clinical use and interpretation of the lung function evaluations during EVLP in determining transplant suitability resides exclusively with the transplant surgeon.

Like in any other clinical decision, all available data should be taken into consideration when determining the suitability of an organ for transplantation; that is, the transplant surgeon is clinically satisfied with the lung evaluation. This criterion should take priority, since the transplant surgeon is the ultimate responsible person for safely transplanting EVLP lungs. The use of the EVLP lung physiologic evaluations in determining transplantability (e.g., EVLP transplantability criteria) has been evaluated in the clinical studies, including the NOVEL trial (see summary of NOVEL study below). Validation has not occurred as to whether the parameters are adequate as surrogates for in vivo performance.

The use of ex-vivo perfusion/ventilation discrete parameters on their own to determine transplant suitability according to the two sets of transplantability criteria used in the NOVEL and NOVEL EXTENSION respectively have not been validated. Clinicians should exercise discretion when using these criteria as the main decision-making tool for transplantability and instead utilize the perfusion/ventilation trends coupled with EVLP x-rays and bronchoscopies and their clinical expertise to make decisions on transplant suitability. Two different transplant suitability criteria (NOVEL: 2 consecutive delta PaO2s ≥ 350 vs NOVEL Extension: 2 non-consecutive delta PaO2s ≥ 350 OR 1 absolute PaO2 > 400) have been used in the NOVEL and NOVEL EXTENSION respectively, and neither of these criteria have been validated. The transplant suitability criteria between the NOVEL and NOVEL Extension studies have shown no difference in survival and/or incidence of Primary Graft Dysfunction (PGD).

Potential Adverse Events

The XPS™ with STEEN Solution™ Perfusate device is indicated for use only on previously unacceptable excised donor lungs in an ex vivo setting. There is no direct patient contact when this device is used as labeled; however, the device has a direct contact with the lungs that are subsequently transplanted into the recipients. The donor lung quality and optimization after preservation have direct effects on allograft function and survival.

The potential for contamination and mechanical trauma, due to the manipulation and cannulation of the lung airway and vascular structures, may lead to complications after transplantation.

Patients receiving a lung treated with the XPS™ System with STEEN Solution™ Perfusate device may experience adverse events including those experienced with any lung transplant.

Indication

Indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.

Prescription Information

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. See the Physician Labeling for further detailed information. For further information, please call (303) 395-9171 and/or consult XVIVO’s website at www.xvivoperfusion.com.

XVIVOISIhcpMar20