Yes. A single lung can be perfused on the XPS.

Yes. Get working on finding a source of Perfadex right away. If donor happens to be at a lung transplant center your team can likely source some from there, if not check with the OPO and see if they can provide Perfadex or can source some locally.

Also have the heart team be sure that the OPO has lung labels available; they may need to have some brought from their OPO office. If the office is far away the printed OPTN label has all of the required information printed on it. Discuss options with the OPO as they are responsible for the labeling per OPTN policy 16.2.

Yes, there are a couple of scenarios for splitting of the lungs

  • If the lungs arrive to LBE and one of them appears to be in a condition not conducive to EVLP the Specialist may contact you and LBE’s on-call Consultant to discuss if the lungs should be split before going on EVLP.
  • If the lungs are on EVLP and one lung is performing poorly but the other seems to be doing better, it is possible to split the lungs while perfused. If this occurs, the airway leading to the lung to be excluded is stapled or clamped and the pulmonary artery leading to the lung being excluded is tied off. The lung remains in position until the end of the procedure when it will be completely separated on the backtable.
  • If the lungs will be heading to two separate recipients, LBE is able to split the lungs post EVLP and package them separately. We are limited by the amount of blood and tissue typing materials provided with the organ which will be discussed at the time of splitting.

Packaging of the lungs is regulated by OPTN policy 16.3. Please note that the policy specifies the organ must be shipped in a disposable shipping box, a cooler can only be used if a member of the recovery team accompanies the organ. The box used for lungs is typically the same type of box OPOs use for livers.

ACIN is the AOPO Credentials Information Network. All surgeons who perform organ recoveries in the USA must be listed in this database along with the organs they are credentialed for. The credentialing for a surgeon is handled by their local OPO, if you need to confirm that a surgeon is credentialed to recover lungs or to learn more about ACIN, please contact your local OPO or the OPO where the donor is located.

The transplant center and/or OPO are in charge of arranging air and donor/transplant hospital local ground transportation and LBE is responsible for ground local transportation to and from the EVLP facility. If for whatever reason transportation arrangements cannot be made expeditiously, Lung Bioengineering is able to assist in air and ground transportation logistics. An EVLP Specialist contacts the appropriate transplant center personnel to ensure that lungs are imported and exported as quickly as possible. The air and/or ground transportation cost involved with the import of lungs to LBE facilities from the donor location are paid for by LBE regardless of EVLP outcome to transplant. Air and/or ground transportation cost for exporting lungs to an accepting transplant center are also paid by LBE. For reimbursement of transportation costs, LBE must be aware of the method of transportation in advance of any lung import/export activity, and the cost to be paid by LBE must be reasonable.

The EVLP fee paid to Lung Bioengineering includes all expenses from the time the organ gets on the ambulance at the donor hospital until it arrives at your transplant center. This includes the cost of getting the organ to the Lung Bioengineering facility (reasonable ground and air transport), cost of professional services related to the EVLP of the organ, all supplies, all laboratory testing, consultation with Lung Bioengineering’s EVLP consultants, and the cost of getting the organ to your transplant center if it is accepted for transplant (reasonable ground and air transport). The fee does not cover getting your recovery team to and from the procurement or the organ acquisition fee charged by the donor OPO.

Yes, please reach out to info@lungbioengineering.com for assistance in obtaining those materials for your center.

Please see our reimbursement guide for more info.

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The transplant center and/or OPO are in charge of arranging air and donor/transplant hospital local ground transportation and LBE is responsible for ground local transportation to and from the EVLP facility. If for whatever reason transportation arrangements cannot be made expeditiously, Lung Bioengineering is able to assist in air and ground transportation logistics. An EVLP Specialist contacts the appropriate transplant center personnel to ensure that lungs are imported and exported as quickly as possible. The air and/or ground transportation cost involved with the import of lungs to LBE facilities from the donor location are paid for by LBE regardless of EVLP outcome to transplant. Air and/or ground transportation cost for exporting lungs to an accepting transplant center are also paid by LBE. For reimbursement of transportation costs, LBE must be aware of the method of transportation in advance of any lung import/export activity, and the cost to be paid by LBE must be reasonable.

Lungs should be packaged according to OPTN policy for unaccompanied organs and include tissue typing material and blood.

To purchase insulated containers for shipping, please visit https://www.fishersci.com/ (item number is SG-9W)

WWW.FISHERSCI.COM

The OPTN policy can be accessed at the following address: https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf

OPTN POLICY

EVLP begins once lung perfusion starts on the EVLP circuit. The EVLP procedure runs for a minimum of 3 hours up to a maximum of 5 hours.

Yes. It is possible for two lungs from a single donor to be sent for EVLP en bloc at LBE facilities, separated and sent to intended recipients at two different transplant centers.

If EVLP demonstrates that the lung(s) are suitable for transplantation and the requesting center declines them, the host OPO will be notified. There are circumstances when the OPO will have the option to place the lungs with another partner program. All allocation is to be completed by the host OPO. Lungs that are not approved for transplant are referred back to the organ procurement organization for final disposition.

From the time LBE receives notification from the transplant center to begin cooldown, it takes approximately 35-40 minutes to get the organ out the door, into the awaiting ground transportation.

From LB1- Silver Spring, Maryland to the local FBO, ground time is approximately 30 minutes. After that, factor in-flight time to your airport, ground time to your hospital, the time to get the lung up to your OR, and bench and implant times before the first lung is reperfused to get a total CIT2.

From LB2- Jacksonville, Florida, to the local FBO, ground time is approximately 15 minutes. After that, factor in-flight time to your airport, ground time to your hospital, the time to get the lung up to your OR, and bench and implant times before the first lung is reperfused to get a total CIT2.

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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