{"id":7,"date":"2020-04-30T13:00:52","date_gmt":"2020-04-30T17:00:52","guid":{"rendered":"https:\/\/dnable.wpengine.com\/?page_id=7"},"modified":"2021-07-07T15:48:58","modified_gmt":"2021-07-07T19:48:58","slug":"home","status":"publish","type":"page","link":"\/","title":{"rendered":"Home"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7\" class=\"elementor elementor-7\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-df7c030 elementor-section-full_width elementor-section-height-min-height elementor-section-items-stretch elementor-section-content-top elementor-section-height-default\" data-id=\"df7c030\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-a929e75\" data-id=\"a929e75\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-166f14f elementor-widget elementor-widget-heading\" data-id=\"166f14f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ex-vivo Lung Perfusion Pioneers<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eeb990d elementor-widget elementor-widget-text-editor\" data-id=\"eeb990d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Lung Bioengineering utilizes the first FDA-approved EVLP technology on the market* and offers the only centralized EVLP service in the United States.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5eaa3c8 elementor-widget elementor-widget-button\" data-id=\"5eaa3c8\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"\/hcp\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">LEARN MORE<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2475dc1 elementor-widget elementor-widget-text-editor\" data-id=\"2475dc1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<h6>*XVIVO Perfusion System (XPS\u2122) with STEEN Solution\u2122<\/h6>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-835d850 elementor-widget elementor-widget-heading\" data-id=\"835d850\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">\u00a9 2021 Lung Bioengineering | All rights reserved. <br>www.lungbioengineering.com | US-LBE-XPS-0010<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-e12f392 elementor-hidden-tablet elementor-hidden-phone\" data-id=\"e12f392\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7dde8b9 elementor-widget elementor-widget-image\" data-id=\"7dde8b9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-image\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/\">\n\t\t\t\t\t\t\t<img src=\"\/wp-content\/uploads\/2020\/04\/LBE_LOGO_Green_Copy.svg\" class=\"attachment-full size-full\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24f8447 elementor-widget elementor-widget-heading\" data-id=\"24f8447\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">24 HOUR REFERRAL LINE<\/h5>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b71e76 elementor-widget elementor-widget-heading\" data-id=\"8b71e76\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">1-844-367-3857<\/h5>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad8654f elementor-widget elementor-widget-text-editor\" data-id=\"ad8654f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Lung Bioengineering provides centralized ex vivo lung perfusion (EVLP) in facilities staffed around the clock to serve multiple lung transplant centers<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c000d4a elementor-widget elementor-widget-text-editor\" data-id=\"c000d4a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>We utilize two separate platforms to perform EVLP based on clinician preference.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-aebdddc\" data-id=\"aebdddc\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-99aef44 elementor-widget elementor-widget-heading\" data-id=\"99aef44\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Clinical Trial Protocol <br> <span style=\"font-size: 0.6em;\">EVP-DEV-LTX-301<\/span><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4454aa3 elementor-widget elementor-widget-heading\" data-id=\"4454aa3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Lung Bioengineering is currently conducting a Centralized Lung Evaluation System (CLES) clinical trial.<\/h5>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb3c1b0 elementor-widget elementor-widget-button\" data-id=\"fb3c1b0\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"\/clinicaltrial-03641677\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">LEARN MORE<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8262b34 elementor-widget elementor-widget-heading\" data-id=\"8262b34\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Disclaimer: The CLES is not an approved device in any jurisdiction.<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8eab3d5 elementor-widget elementor-widget-heading\" data-id=\"8eab3d5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">\u00a9 2021 Lung Bioengineering | All rights reserved. <br>\nwww.lungbioengineering.com | MED-GEN-US-0102<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-20b2a95 elementor-section-full_width safety-overlay elementor-section-height-default elementor-section-height-default\" data-id=\"20b2a95\" data-element_type=\"section\" id=\"isibar\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c74a775\" data-id=\"c74a775\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2335f3f elementor-absolute elementor-widget elementor-widget-template\" data-id=\"2335f3f\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<section data-elementor-type=\"section\" data-elementor-id=\"40\" class=\"elementor elementor-40\" data-elementor-settings=\"[]\">\n\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-f3a3420 elementor-section-full_width safety-information-screen elementor-section-height-default elementor-section-height-default\" data-id=\"f3a3420\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-98138af\" data-id=\"98138af\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-12ebfaf elementor-widget elementor-widget-heading\" data-id=\"12ebfaf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">IMPORTANT SAFETY INFORMATION FOR XVIVO PERFUSION SYSTEM (XPS\u2122) WITH STEEN SOLUTION\u2122 PERFUSATE - P180014<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-feb29d0 elementor-widget elementor-widget-heading\" data-id=\"feb29d0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warnings and Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ab5ef9 elementor-widget elementor-widget-heading\" data-id=\"3ab5ef9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">General Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf62abf elementor-widget elementor-widget-text-editor\" data-id=\"cf62abf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tThe safety and effectiveness of the XPS\u2122 System with Steen Solution\u2122 perfusate device were not evaluated with ideal criteria donor lungs.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e67161 elementor-widget elementor-widget-heading\" data-id=\"0e67161\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Risk for Contamination and Mechanical Trauma<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc902ae elementor-widget elementor-widget-text-editor\" data-id=\"bc902ae\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ff1e8d elementor-widget elementor-widget-heading\" data-id=\"4ff1e8d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XPS<sup>TM<\/sup> Machine Operation-Related Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd2e917 elementor-widget elementor-widget-text-editor\" data-id=\"fd2e917\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSee Warnings and Precautions in the XPS<sup>TM<\/sup> System Instructions for Use manual.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3855a6b elementor-widget elementor-widget-heading\" data-id=\"3855a6b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">STEEN Solution<sup>TM<\/sup> Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a109d8 elementor-widget elementor-widget-text-editor\" data-id=\"8a109d8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11cb79e elementor-widget elementor-widget-heading\" data-id=\"11cb79e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Lung Cannula Set<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d477044 elementor-widget elementor-widget-text-editor\" data-id=\"d477044\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12af592 elementor-widget elementor-widget-heading\" data-id=\"12af592\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Organ Chamber<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76c50d6 elementor-widget elementor-widget-text-editor\" data-id=\"76c50d6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f54d5c0 elementor-widget elementor-widget-heading\" data-id=\"f54d5c0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Disposable Lung Circuit<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe69b1f elementor-widget elementor-widget-text-editor\" data-id=\"fe69b1f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d65083d elementor-widget elementor-widget-heading\" data-id=\"d65083d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Disposable Lung Kit<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b603ac8 elementor-widget elementor-widget-text-editor\" data-id=\"b603ac8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9ed7baf elementor-widget elementor-widget-heading\" data-id=\"9ed7baf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XPS<sup>TM<\/sup> Machine Operation-Related Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aa94bff elementor-widget elementor-widget-text-editor\" data-id=\"aa94bff\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSee Warnings and Precautions in the XPS<sup>TM<\/sup> System Instructions for Use manual.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d903b2 elementor-widget elementor-widget-heading\" data-id=\"2d903b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">STEEN Solution<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cae2db elementor-widget elementor-widget-text-editor\" data-id=\"0cae2db\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSTEEN Solution<sup>TM<\/sup> is intended for single use only and MAY NOT BE REUSED. Any leftover solution must be disposed of after the procedure.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b438216 elementor-widget elementor-widget-text-editor\" data-id=\"b438216\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p><strong>Do not use STEEN Solution<sup>TM<\/sup>\u00a0if the solution is not clear, the bottle is damaged, the flip-tear seal has been tampered with, or if the \u201cuse by\u201d date has expired. Transplant Suitability Post-Ex Vivo Lung Perfusion (EVLP)<\/strong> 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.<\/p><p>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.<\/p><p>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 \u2265 350 vs NOVEL Extension: 2 non-consecutive delta PaO2s \u2265 350 OR 1 absolute PaO2 &gt; 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).<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1661f12 elementor-widget elementor-widget-heading\" data-id=\"1661f12\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Potential Adverse Events<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b34e4d elementor-widget elementor-widget-text-editor\" data-id=\"2b34e4d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>The XPS<sup>TM<\/sup> with STEEN Solution<sup>TM<\/sup> 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.<br \/><br \/>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.<br \/><br \/>Patients receiving a lung treated with the XPS<sup>TM<\/sup> System with STEEN Solution<sup>TM<\/sup> Perfusate device may experience adverse events including those experienced with any lung transplant.<br \/><br \/>Below is a list of the potential adverse effects associated with the use of the device.<\/p><ul><li>Death<\/li><li>Renal failure or dysfunction<\/li><li><span style=\"background-color: transparent;\">Respiratory dysfunction or failure<\/span><\/li><li>Respiratory infection<\/li><li>Sepsis<\/li><li>Primary graft dysfunction<\/li><li>Acute or chronic rejection<\/li><li>Cardiac arrhythmias<\/li><li>Bronchiolitis Obliterans Syndrome (BOS)<\/li><li>Bronchial stenosis\/Dehiscence<\/li><li>Post-operative bleeding\/hemorrhage<\/li><li>Hemothorax<\/li><li>Pneumothorax<\/li><li>Re-transplantation<\/li><\/ul>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1e2f17 elementor-widget elementor-widget-heading\" data-id=\"c1e2f17\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Indication<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5db0078 elementor-widget elementor-widget-text-editor\" data-id=\"5db0078\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e7b4383 elementor-widget elementor-widget-heading\" data-id=\"e7b4383\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prescription Information<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f25520 elementor-widget elementor-widget-text-editor\" data-id=\"3f25520\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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\u2019s website at www.xvivoperfusion.com.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5cda84 elementor-widget elementor-widget-text-editor\" data-id=\"c5cda84\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>XVIVOISIhcpMar20<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-5b1c5e6\" data-id=\"5b1c5e6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-38917ce elementor-widget__width-auto elementor-align-center arrow_icon_cs elementor-widget elementor-widget-button\" data-id=\"38917ce\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\" id=\"btn-expand-overlay\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"23\" height=\"40\" viewBox=\"0 0 23 40\"><g transform=\"translate(0 40)\"><g transform=\"translate(0 -40)\"><rect width=\"23\" height=\"40\" fill=\"#a0a0a0\"><\/rect><path d=\"M17,17.614,11.5,12,6,17.614l1.15,1.174,3.529-3.6V27h1.642V15.184l3.529,3.6Z\" fill=\"#fff\"><\/path><\/g><\/g><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Click to expand<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-536ee93 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"536ee93\" data-element_type=\"section\" id=\"isi\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-44aaa57\" data-id=\"44aaa57\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5015ca8 elementor-absolute elementor-widget elementor-widget-template\" data-id=\"5015ca8\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<section data-elementor-type=\"section\" data-elementor-id=\"201\" class=\"elementor elementor-201\" data-elementor-settings=\"[]\">\n\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t<div class=\"elementor-section elementor-top-section elementor-element elementor-element-7d3c8bf9 elementor-section-full_width safety-information-screen elementor-section-height-default elementor-section-height-default\" data-id=\"7d3c8bf9\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-93b2f00\" data-id=\"93b2f00\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a710e3b elementor-widget elementor-widget-heading\" data-id=\"a710e3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">IMPORTANT SAFETY INFORMATION FOR XVIVO PERFUSION SYSTEM (XPS\u2122) WITH STEEN SOLUTION\u2122 PERFUSATE - P180014<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d2b431 elementor-widget elementor-widget-heading\" data-id=\"2d2b431\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warnings and Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a0b7634 elementor-widget elementor-widget-heading\" data-id=\"2a0b7634\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">General Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29200207 elementor-widget elementor-widget-text-editor\" data-id=\"29200207\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tThe safety and effectiveness of the XPS\u2122 System with Steen Solution\u2122 perfusate device were not evaluated with ideal criteria donor lungs.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20b2aa18 elementor-widget elementor-widget-heading\" data-id=\"20b2aa18\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Risk for Contamination and Mechanical Trauma<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d7ba86d elementor-widget elementor-widget-text-editor\" data-id=\"6d7ba86d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67235320 elementor-widget elementor-widget-heading\" data-id=\"67235320\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XPS<sup>TM<\/sup> Machine Operation-Related Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65ec3e1b elementor-widget elementor-widget-text-editor\" data-id=\"65ec3e1b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSee Warnings and Precautions in the XPS<sup>TM<\/sup> System Instructions for Use manual.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6abc2680 elementor-widget elementor-widget-heading\" data-id=\"6abc2680\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">STEEN Solution<sup>TM<\/sup> Warnings<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1026a27a elementor-widget elementor-widget-text-editor\" data-id=\"1026a27a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-349206bd elementor-widget elementor-widget-heading\" data-id=\"349206bd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Lung Cannula Set<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7fc523be elementor-widget elementor-widget-text-editor\" data-id=\"7fc523be\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2eed3152 elementor-widget elementor-widget-heading\" data-id=\"2eed3152\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Organ Chamber<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb51904 elementor-widget elementor-widget-text-editor\" data-id=\"cb51904\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33760a11 elementor-widget elementor-widget-heading\" data-id=\"33760a11\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Disposable Lung Circuit<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12115ea6 elementor-widget elementor-widget-text-editor\" data-id=\"12115ea6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-452d19d elementor-widget elementor-widget-heading\" data-id=\"452d19d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XVIVO Disposable Lung Kit<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6cec8c13 elementor-widget elementor-widget-text-editor\" data-id=\"6cec8c13\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>Store at room temperature. Use only undamaged\/unopened containers. Single Use Only.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-38b79f2f elementor-widget elementor-widget-heading\" data-id=\"38b79f2f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">XPS<sup>TM<\/sup> Machine Operation-Related Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53af4a88 elementor-widget elementor-widget-text-editor\" data-id=\"53af4a88\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSee Warnings and Precautions in the XPS<sup>TM<\/sup> System Instructions for Use manual.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d20277c elementor-widget elementor-widget-heading\" data-id=\"1d20277c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">STEEN Solution<sup>TM<\/sup> Precautions<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26be42ed elementor-widget elementor-widget-text-editor\" data-id=\"26be42ed\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\tSTEEN Solution<sup>TM<\/sup> is intended for single use only and MAY NOT BE REUSED. Any leftover solution must be disposed of after the procedure.\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-14749c1b elementor-widget elementor-widget-text-editor\" data-id=\"14749c1b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p><strong>Do not use STEEN Solution<sup>TM<\/sup>\u00a0if the solution is not clear, the bottle is damaged, the flip-tear seal has been tampered with, or if the \u201cuse by\u201d date has expired. Transplant Suitability Post-Ex Vivo Lung Perfusion (EVLP)<\/strong> 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.<\/p><p>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.<\/p><p>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 \u2265 350 vs NOVEL Extension: 2 non-consecutive delta PaO2s \u2265 350 OR 1 absolute PaO2 &gt; 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).<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48184a3e elementor-widget elementor-widget-heading\" data-id=\"48184a3e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Potential Adverse Events<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e8df494 elementor-widget elementor-widget-text-editor\" data-id=\"7e8df494\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>The XPS<sup>TM<\/sup> with STEEN Solution<sup>TM<\/sup> 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.<br \/><br \/>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.<br \/><br \/>Patients receiving a lung treated with the XPS<sup>TM<\/sup> System with STEEN Solution<sup>TM<\/sup> Perfusate device may experience adverse events including those experienced with any lung transplant.<br \/><br \/>Below is a list of the potential adverse effects associated with the use of the device.<\/p><ul><li>Death<\/li><li>Renal failure or dysfunction<\/li><li><span style=\"background-color: transparent;\">Respiratory dysfunction or failure<\/span><\/li><li>Respiratory infection<\/li><li>Sepsis<\/li><li>Primary graft dysfunction<\/li><li>Acute or chronic rejection<\/li><li>Cardiac arrhythmias<\/li><li>Bronchiolitis Obliterans Syndrome (BOS)<\/li><li>Bronchial stenosis\/Dehiscence<\/li><li>Post-operative bleeding\/hemorrhage<\/li><li>Hemothorax<\/li><li>Pneumothorax<\/li><li>Re-transplantation<\/li><\/ul>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-796ad7e6 elementor-widget elementor-widget-heading\" data-id=\"796ad7e6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Indication<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61b86240 elementor-widget elementor-widget-text-editor\" data-id=\"61b86240\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e4a3515 elementor-widget elementor-widget-heading\" data-id=\"2e4a3515\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prescription Information<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4837249a elementor-widget elementor-widget-text-editor\" data-id=\"4837249a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>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\u2019s website at www.xvivoperfusion.com.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a759904 elementor-widget elementor-widget-text-editor\" data-id=\"6a759904\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>XVIVOISIhcpMar20<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-3ad36beb\" data-id=\"3ad36beb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6583fd53 elementor-widget__width-auto elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-phone elementor-widget elementor-widget-button\" data-id=\"6583fd53\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"23\" height=\"40\" viewBox=\"0 0 23 40\"><g transform=\"translate(0 40)\"><g transform=\"translate(0 -40)\"><rect width=\"23\" height=\"40\" fill=\"#a0a0a0\"><\/rect><path d=\"M17,17.614,11.5,12,6,17.614l1.15,1.174,3.529-3.6V27h1.642V15.184l3.529,3.6Z\" fill=\"#fff\"><\/path><\/g><\/g><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Click to expand<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Ex-vivo Lung Perfusion Pioneers Lung Bioengineering utilizes the first FDA-approved EVLP technology on the market* and offers the only centralized EVLP service in the United States. LEARN MORE *XVIVO Perfusion System (XPS\u2122) with STEEN Solution\u2122 \u00a9 2021 Lung Bioengineering | All rights reserved. www.lungbioengineering.com | US-LBE-XPS-0010 24 HOUR REFERRAL LINE 1-844-367-3857 Lung Bioengineering provides centralized [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_mi_skip_tracking":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v14.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Lung Bioengineering | Centralized Ex Vivo Lung Perfusion<\/title>\n<meta name=\"description\" content=\"Lung Bioengineering is dedicated to increasing the utilization of marginal lungs through vital reconditioning technology\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lung Bioengineering | Centralized Ex Vivo Lung Perfusion\" \/>\n<meta property=\"og:description\" content=\"Lung Bioengineering is dedicated to increasing the utilization of marginal lungs through vital reconditioning technology\" \/>\n<meta property=\"og:url\" content=\"\/\" \/>\n<meta property=\"og:site_name\" content=\"LUNG BIOENGINEERING\" \/>\n<meta property=\"article:modified_time\" content=\"2021-07-07T19:48:58+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"\/#organization\",\"name\":\"Lung Bioengineering\",\"url\":\"\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"\/#logo\",\"inLanguage\":\"en-US\",\"url\":\"\/wp-content\/uploads\/2020\/04\/LBE_LOGO_Green_Copy.svg\",\"caption\":\"Lung Bioengineering\"},\"image\":{\"@id\":\"\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"\/#website\",\"url\":\"\/\",\"name\":\"LUNG BIOENGINEERING\",\"description\":\"LEADING THE FUTURE OF LUNG TRANSPLANTATION AS THE ONLY EVLP SERVICE IN THE UNITED STATES\",\"publisher\":{\"@id\":\"\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"\/#webpage\",\"url\":\"\/\",\"name\":\"Lung Bioengineering | Centralized Ex Vivo Lung Perfusion\",\"isPartOf\":{\"@id\":\"\/#website\"},\"datePublished\":\"2020-04-30T17:00:52+00:00\",\"dateModified\":\"2021-07-07T19:48:58+00:00\",\"description\":\"Lung Bioengineering is dedicated to increasing the utilization of marginal lungs through vital reconditioning technology\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"\/\"]}]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","_links":{"self":[{"href":"\/wp-json\/wp\/v2\/pages\/7"}],"collection":[{"href":"\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"\/wp-json\/wp\/v2\/comments?post=7"}],"version-history":[{"count":54,"href":"\/wp-json\/wp\/v2\/pages\/7\/revisions"}],"predecessor-version":[{"id":322,"href":"\/wp-json\/wp\/v2\/pages\/7\/revisions\/322"}],"wp:attachment":[{"href":"\/wp-json\/wp\/v2\/media?parent=7"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}