24-HOUR EVLP REFERRAL LINE

1-844-367-3857

For any other inquiries, please reach us via Contact Us tab.

24-HOUR EVLP REFERRAL LINE
1-844-367-3857

For any other inquiries, please reach us via Contact Us tab.

Privacy Policy

PLEASE READ THIS PRIVACY STATEMENT CAREFULLY.

Privacy is very important to us. We also understand that privacy is very important to you. This Privacy Statement tells you how we protect and use information that we gather through this Lung Biotechnology PBC (“Lung Biotechnology”) (formerly known as Lung Biotechnology Inc.) Web site. Lung Biotechnology and its affiliates also operate other Web sites.

This Privacy Statement does not apply to the other Lung Biotechnology Web sites. You should review the privacy statement posted on other Lung Biotechnology Web sites when you visit them. This Web site and this Privacy Statement are intended only for audiences in the U.S. This Privacy Statement was last revised on March 20, 2015. We may change this Privacy Statement at any time and for any reason. Significant changes to the Privacy Statement are discussed below in the Section called “Changes to the Privacy Statement.” We encourage you to review this Privacy Statement each time you visit the Web site.

By using this Web site, you agree to the terms of the most recent version of this Privacy Statement. Please read our Terms of Use to understand the general rules about your use of this Web site. Except as written in any other disclaimers, policies, Terms of Use, or other notices on this Web site, this Privacy Statement and the Terms of Use are the complete agreement between you and Lung Biotechnology with respect to your use of this Web site.

INTRODUCTION

We are pleased to post this policy so that users understand how we utilize the information they provide us. For other important information concerning your use of our site, please refer to our Terms of Use. Lung Biotechnology respects the privacy of those who use its site. Users should understand, however, that by the very nature of the medium, their communications with us, such as postings to the site or e-mail, reveal their e-mail addresses and other potentially identifying information. The information we receive, and how we use it, depends on what you do when visiting our Web site. We collect and use your non-personal information (information that is not identifiable to you personally) differently than your personal information.

WHAT IS NON-PERSONAL INFORMATION?

Non-personal information is information we collect through this Web site that does not identify you as an individual person. It includes any of the following items:

  • the type of Web browser software you use (for example, Netscape Navigator or Internet Explorer);
  • the name of the domain from which you access the Internet (including client and server IP addresses, usernames, ports, queries, or other status-related information);
  • the Internet address of the Web site from which you linked directly to our Web site;
  • the date and time you access our Web site;
  • which pages you have visited on our Web site;

WHAT DOES LUNG BIOTECHNOLOGY DO WITH NON-PERSONAL INFORMATION?

Because non-personal information cannot identify you or be tied to you in any way, there are few restrictions on the ways that we can use or share non-personal information. Primarily, we will use this data to make enhancements to the Web site that are specifically tailored to improve the experience of the user community. One way that we use non-personal information is to demonstrate user trends on the Web site. Often, this is done by aggregating the data gleaned from non-personal information. This aggregated, de-identified data might be shared with outside parties who are employed to implement improvements to the site.

WHAT IS PERSONAL INFORMATION?

Personal information is information we collect through this Web site that we can use to specifically identify you, such as your:

  • name
  • telephone number
  • e-mail address
  • state of residence
  • age range
  • gender
  • whether you are a patient, caregiver, healthcare professional, or a job applicant
  • why you are participating in the program

In some places on this Web site you have the opportunity to send us personal information about yourself. For example, you may fill out a registration form, an application, a survey, or an e-mail form.

Any personal information that you enter on this Web site will not be revealed to third parties or used for any purpose outside of Lung Biotechnology, other than as explicitly stated at the point of information collected.

HOW DOES LUNG BIOTECHNOLOGY KEEP AND USE PERSONAL INFORMATION?

Please note, Lung Biotechnology is not a covered entity under HIPAA (The Health Insurance Portability and Accountability Act of 1996). Therefore, information you submit to us will not be subject to protections under HIPAA. When you submit information to us on this Website, you are giving Lung Biotechnology permission to use your personal information to communicate with you. Your information will never be shared with a third party, except as outlined below.We may keep and use personal information we collect from you through this Web site to provide you with access to this Web site. In addition, we may keep and use your personal information:

  • to send you information you requested
  • to respond to your requests
  • to develop records, including records of your personal information
  • for internal program monitoring.
  • to remove your personal identifiers (your name, e-mail address, etc). In this case, you would no longer be identified as a single unique individual. Once we have de-identified information, it is non-personal information and we may treat it like other non-personal information.
  • to enforce this Privacy Statement and other rules about your use of this Web site • to protect our rights or property
  • to protect someone’s health, safety, or welfare
  • to comply with a law or regulation, court order or other legal process

We will not use, sell, or assign your e-mail address for any purpose other than to communicate with you about Lung Biotechnology products. If you create a password it will be used to help keep your information secure and verify your identity when you submit information to us.

DOES LUNG BIOTECHNOLOGY EVER SHARE PERSONAL INFORMATION WITH THIRD PARTIES?

Lung Biotechnology will not share your personal information collected from this Web site with an unrelated third party without your permission.

In the ordinary course of business, we will share some personal information with companies that we hire to perform services or functions on our behalf. For example, we employ a company to develop and maintain this Web site. In this case, the company will have access to your personal information in the ordinary course of business. However, in this instance, and all instances in which your personal information is shared with a third party, we will not authorize them to keep, disclose, or use your information with others except for the purpose of providing the services we asked them to provide. We will not sell, exchange, or publish your personal information, except in conjunction with a corporate sale, merger, dissolution, or acquisition.

We may be legally compelled to release your personal information in response to a court order, subpoena, search warrant, law, or regulation. We may cooperate with law enforcement authorities in investigating and prosecuting Web site visitors who violate our rules or engage in behavior which is harmful to other visitors (or illegal).

We may disclose your personal information to third parties if we feel that the disclosure is necessary to:

  • enforce this Privacy Statement and the other rules about your use of this Web site
  • protect our rights or property
  • protect someone’s health, safety, or welfare
  • comply with a law or regulation, court order, or other legal process

Please note: In addition to the ways that we may keep, disclose, and use information described in this Privacy Statement, we also may keep, disclose, and use personally identifiable information that you give us through this Web site in ways that we believe are required by applicable law.

WHAT HAPPENS IF THE PRIVACY STATEMENT CHANGES?

Lung Biotechnology reserves the right to change the terms of our Privacy Statement at any time in its sole discretion. Please periodically revisit this page to stay current on any changes and to update your preferences accordingly.

WHAT ABOUT PRIVACY ON OTHER WEB SITES?

his Web site may contain links to other Web sites. Some of those Web sites may be operated by Lung Biotechnology, and some may be operated by third parties. We provide the links for your convenience, but we do not review, control, or monitor the activities or privacy practices of Web sites operated by others, and we do not endorse, condone, adopt, or accept liability for any statements made on Web sites to which we provide links. This Privacy Statement does not apply to any other Web site, even those owned by Lung Biotechnology. We are not responsible for the performance of Web sites operated by third parties or for your business dealings with them. Therefore, whenever you leave this Web site, we recommend that you review each Web site’s privacy practices and make your own conclusions regarding the adequacy of these practices.

DOES LUNG BIOTECHNOLOGY EVER COMMUNICATE DIRECTLY WITH VISITORS TO THIS WEB SITE?

If you express a desire to be contacted by us and provide your contact information, we may contact you periodically by e-mail, mail, or telephone to provide information regarding programs, services and content that may be of interest to you. In addition, some of the features on this Web site allow you to communicate with us using an online form. If your communication requests a response from us, we may send you a response via e-mail or get in touch with you by telephone. The e-mail response or confirmation may include your personal information, including personal information about your health, your name, address, etc. We cannot guarantee that our e-mails to you will be secure from unauthorized interception.

ARE THERE SPECIAL RULES ABOUT CHILDREN’S PRIVACY?

We care about protecting the online privacy of children. This Web site is not intended for use by children under the age of 18. We will not intentionally collect any personal information (such as a child’s name or e-mail address) from children under the age of 18. If you are a child under age 18, please do not send us any information about yourself. If you think that we have collected personal information from a child under the age of 18, please contact us. We encourage all parents and guardians to monitor their children’s use of the internet.

WHAT ABOUT WEB SITE SECURITY?

We take reasonable steps to protect your personal information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail.

HOW TO CONTACT LUNG BIOTECHNOLOGY

If you have questions or comments about this Privacy Statement, please contact: Office of General Counsel Lung Biotechnology PBC legal@unither.com

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.

XPSTM Machine Operation-Related Warnings

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

STEEN SolutionTM 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 SetTM Precautions

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

XVIVO Organ ChamberTM Precautions

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

XVIVO Disposable Lung CircuitTM Precautions

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

XVIVO Disposable Lung KitTM Precautions

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

XPSTM Machine Operation-Related Precautions

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

STEEN SolutionTM Precautions

STEEN SolutionTM 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 SolutionTM 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 XPSTM with STEEN SolutionTM 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 XPSTM System with STEEN SolutionTM Perfusate device may experience adverse events including those experienced with any lung transplant.

Below is a list of the potential adverse effects associated with the use of the device.

  • Death
  • Renal failure or dysfunction
  • Respiratory dysfunction or failure
  • Respiratory infection
  • Sepsis
  • Primary graft dysfunction
  • Acute or chronic rejection
  • Cardiac arrhythmias
  • Bronchiolitis Obliterans Syndrome (BOS)
  • Bronchial stenosis/Dehiscence
  • Post-operative bleeding/hemorrhage
  • Hemothorax
  • Pneumothorax
  • Re-transplantation

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.

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