OUR CENTRALIZED EVLP SERVICE

Lung Bioengineering’s centralized EVLP service model supports transplant centers by removing barriers and providing touchpoints at every step of the donation and transplantation process in order to optimize organ utilization.

We offer a seamless customer experience for the FDA approved XPS EVLP technology to deliver an unrivalled solution for EVLP services and logistics.

Benefits of our Service Arrow Icon

Our centralized EVLP service model reduces costs, minimizes risk and allows for expansion of the pool of usable donor lungs.

01

HIGHLY SKILLED AND EXPERIENCED TEAM

Lung Bioengineering’s clinical staff is comprised of EVLP Specialists with extensive experience and qualifications. Our team is supported by dedicated Quality Assurance and AV/IT personnel who ensure data accuracy and seamless real-time audio visual communication with our transplant center partners throughout EVLP procedures. Available at any time, we work around the clock to deliver the highest standard of service.

02

ONE-OF-A-KIND SPECIALIZED CENTERS

Located in Silver Spring, Maryland, and Jacksonville, Florida, Lung Bioengineering’s combined 53,000 ft2 facilities offer 9 procedure rooms. Each of our suites is designed with specialized A/V equipment to provide transplant centers with total virtual oversight throughout the EVLP process.

03

IN-DEPTH VIRTUAL LUNG EVALUATION

CASE MANAGEMENT EXCHANGE (XMX) is a clinical decision support system that provides continuous monitoring and data sharing throughout the EVLP process.

This in depth insight presents physicians with an up close and fully-informed virtual experience designed to recreate an in-person evaluation of lungs for transplant. This saves transplant centers time and resources while offering all tools necessary for confidence in decision making.

Service Image - Desktop Service Image - Mobile
04

THE FIRST FDA-APPROVED EVLP TECHNOLOGY ON THE MARKET

XVIVO PERFUSION SYSTEM (XPS™)

with STEEN Solution™

Lung Bioengineering uses the XVIVO Perfusion System (XPS™) to provide centers with the technology to make more informed decisions and improve patients’ chances of receiving a lung for transplant.

05

MEDICAL CONSULTANTS

Medical consultations with physicians having experience using STEEN™ Solution-based EVLP technology are available throughout each procedure.

06

LOGISTICS ASSISTANCE

Lung Bioengineering offers continuous expert guidance as well as hands on support with logistics and transportation.

INTERESTED IN OUR SERVICES?

BECOME A PARTNER

Get started with Lung Bioengineering today. Click to connect with our staff, who are on hand to guide you every step of the way.

JOIN US

ARE YOU ALREADY OUR PARTNER?

FOR PARTNERS

Click to access important partner resources and information.

LEARN MORE

OUR EVLP PROCESS

Lung Bioengineering prides itself on offering a simplified EVLP service that relieves resource, time and financial burdens for its partners. Our process is broken down into 4 steps:

step 1

REFERRAL TO LBE FOR EVLP

Image 0 - Mobile

The transplant center assesses lungs to determine need for EVLP and calls 844-367-3857 to initiate referral.

Lung Bioengineering opens the case in our system. This step includes gathering detailed data about the donor lungs, the organ condition and reason for EVLP.

Images 0-0 - Desktop
step 2

TRANSIT TO LBE FACILITY

Image 1 - Mobile

Donor lungs are recovered and transported to our facility by air and/or ground medical transport. Logistics are arranged by the transplant center with Lung Bioengineering available to support as needed.

ASSISTANCE WITH LOGISTICS
Images 1-0 - Desktop
step 3

EVLP

Image 2 - Mobile

The lungs are cannulated and connected to the EVLP circuit. During EVLP, the lungs are warmed and perfused for a maximum of 5 hours. Our EVLP Specialists perform a bronchoscopy, gas analysis and X-rays. This information is then used by the transplant physician to determine whether the lungs are fit for transplant.

If the transplant physician accepts the lungs for transplant, our EVLP Specialists cool down the lungs and prepare them for transportation.

Images 2-0 - DesktopImages 2-1 - Desktop
step 4

LUNGS ARE ACCEPTED AND SENT TO TRANSPLANT CENTER

Image 3 - Mobile

Donor lungs are transported to the transplant center and the transplantation procedure begins.

Lungs that are not accepted for transplant are referred back to the organ procurement organization for final disposition.

Images 3-0 - Desktop

“Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.”

Author name

“Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.”

Author name

“Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.”

Author name
RECOMMENDED Arrow Icon

HEAR FROM OUR PARTNERS

Click to learn about the Lung Bioengineering experience firsthand from our current partners.

FREQUENTLY ASKED QUESTIONS

READ MORE

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.

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.

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.

BENEFITS OF OUR SERVICE

Our centralized EVLP service model reduces costs, minimizes risk and allows for expansion of the pool of usable donor lungs.

LEARN MORE

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