{"id":876682,"date":"2025-08-18T09:28:19","date_gmt":"2025-08-18T13:28:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/"},"modified":"2025-08-18T09:28:19","modified_gmt":"2025-08-18T13:28:19","slug":"first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/","title":{"rendered":"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>\n          <em>The<\/em><br \/>\n          <em> WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY<\/em>\u00ae <em>Cell-Impermeable Endoprosthesis (CIE).<\/em><\/li>\n<li>\n          <em>The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN.<\/em>\n        <\/li>\n<\/ul>\n<p>SOUTH JORDAN, Utah, Aug.  18, 2025  (GLOBE NEWSWIRE) &#8212; Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry.<\/p>\n<p>The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience such obstructions. The study protocol provides for evaluation of clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, MD, President and Medical Director at Bluff City Vascular and Investigator in the WRAP North America registry, enrolled the first patient in the registry.<\/p>\n<p>\u201cWe appreciate the ingenuity and novelty of the WRAPSODY CIE,\u201d said Dr. Davis. \u201cParticipation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients.\u201d<\/p>\n<p>The superior performance of the WRAPSODY CIE in the clinical trial setting was previously demonstrated in the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial included two arms. In the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5te4WEG715EO_kmBR1c3DRTS2YzvANtRP0XLhiaF8rD20aTdv4VIWd3pNCkffYor1ph1XhA9vN92wyRdjBeNBWvKX456vlPayB_kLO3_1a2tCrhDfK-ksEoHOnjRNRqdd5VUcWc6ivfQd3eVK2wo1RoYncFhnspuoGbrBNcfHvGUMsiJGI_19Qojh3tVkcAr_5NQ7mLk1q5j227lEvmBDaqSxj46aG9R-POwEHlxFK3isO_txkvveX7Qjl5k5AVAo5cc_YPTJ-P0hoy2nX79XzlFGGJ8LvAZREMf11eNCoY=\" rel=\"nofollow\" target=\"_blank\">randomized<\/a> arm, patients with an arteriovenous fistula (AVF) were treated with the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA). In the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5xaFFVqgq-KMhkNeIU2vsAddQLziSEWt5vvd9Y-slQLh_1gVrJUOfx-mTqOWEIVfgI6lzfis6pucq13jZsp7QM-7YXdQLMOT3V_gWMcm-tGyIJOVDE4pmsQf0-3BHH_hCkKR3YgmhIKPAQPG7pKIt9bfc5bFBNlu7fZjsRJH-Bk-L9s9yU--L2zJfci8l05z8pB9vKcApZ7p2dJpzHaYClQozCfYBnh-hn950l_XQJeTkBW2dhpygBH8aUMaLQe3L_yRMV4eVAQlYJuJWJwSw-xYpjGbdAsUWl2RmyfcXLY=\" rel=\"nofollow\" target=\"_blank\">non-randomized<\/a> arm, clinical outcomes of patients with an arteriovenous graft (AVG) were compared to historical outcomes (i.e., performance goals) of AVG patients treated with previous-generation covered stents.<\/p>\n<p>\u201cThe WRAPSODY CIE\u2019s ability to restore vascular access for patients on hemodialysis who experience obstructions is promising,\u201d said David J. Dexter II, MD, FACS, National Principal Investigator of the WRAP North America registry and Vascular Surgeon at Sentara Health Research Center in Norfolk, VA. \u201cThe opportunity to evaluate the WRAPSODY CIE\u2019s real-world effectiveness will help address critical questions regarding the broader impact of its use in clinical practice.\u201d<\/p>\n<p>The WRAP North America registry is intended to add to Merit\u2019s growing portfolio of clinical evidence supporting the WRAPSODY CIE. If completed as designed, it would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.<\/p>\n<p>\u201cThe first patient enrolled in the WRAP North America registry is an important milestone in our ongoing efforts to collect the highest quality of evidence regarding the WRAPSODY CIE\u2019s performance,\u201d said Fred P. Lampropoulos, Merit\u2019s Chairman and Chief Executive Officer. \u201cAdvancing technology that transforms lives through improved patient care is at the heart of what we do. Helping our physician partners shape the future of dialysis is both exciting and rewarding, and we look forward to seeing the difference that the WRAPSODY CIE makes in the lives of many patients.\u201d<\/p>\n<p>Real-world outcomes associated with the use of the WRAPSODY CIE are also being evaluated in the WRAP Global registry, also being conducted by Merit, which was designed to enroll up to 500 patients outside of North America. Final enrollment in the WRAP Global registry is expected by the end of 2025.<\/p>\n<p>For additional information on Merit\u2019s WRAP North America registry, please visit: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rKAZJbVtzW6rfZ4DFMKdnIoM0O-ZSuo2S1U7KKCldkjJKVzcUMCB22LwLfzuK3M8q0qwmFQqtRGhAnT8RPzYWapeoZGZ7Am1Fg92var_fmvJTJkh4lSOKJ5Ur5CEVUU0JIcDZ4QBT20SHfb37SgrOPB70iuQUjSI7aXsftQ0BLM=\" rel=\"nofollow\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT06807099<\/a>.<\/p>\n<p>For additional information on Merit\u2019s WRAP Global registry, please visit: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rKAZJbVtzW6rfZ4DFMKdnMxRts4E04IJrcIVow1GWkdzlPkme5qzT1Nyc0ROBkuQjfL5lDiBCeIxkP35kA8g0V9LsSvBiAOeA4WeLq7S2Gy8Gl9wrwwZ3hDIKMO9vkh26siHkPHJ_9QFj---DVAiZDNoXIEzWo_lTJRMgvpxiP36WMHM8qsxwmZrdSYB-zFh\" rel=\"nofollow\" target=\"_blank\">https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05062291<\/a>.<\/p>\n<p>On December 19, 2024, the WRAPSODY CIE received premarket approval from the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=CrjSlAjAjPWRHPkfcsfwUwp6iNchNlGpqZwPsZqbiUoHNV22Rqf9GoVhDizN3tOJWyQ-y93q85Vga7fJYa6PYAD6BGSi8lefPv6S2ibyxLqoGfDBf9VmW0OFwYqun9Wmm06BC5YYSnNdK6ctzunSbW_5SU4fnyQwYSd7kQ1KRAraN9dawYP2aloso_RLlWxEAwj8gYSD7xS3nJTWbwKmY4crInriexSPxQGW0WICJk_RTEC9GbgZqlYcP3qqOmlLEKTKpTlebM65Be2XDXwiB5H9naGUbR8W9qULKA-kYX8=\" rel=\"nofollow\" target=\"_blank\">US Food and Drug Administration<\/a> (FDA). On April 30, 2025, the device was approved by <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RRUjtkcE0nTcWQiZqBRgH61BR_8GE-oVEBH3mliCx5cY7bD4dfC6-0DnsOd2mkGm1Ha_xDmCZvGXjvJHm4CAUkssI8zV01kVYlPjg4eeKdsZ6Zcvpf-ZzzfIOLUbtJ_RiMXEBweEIEGTzcmmOxSlr8LhKYRa4DGV9dug4KkoVMSBXoO-dhWIBzBBStJEBXeLQOywMJ13crh1HIKe_xNzmpZM41QBSfW5DpUxn7M5uMwuSqDrwZsw8Ef105kvFgqkZKJEigvuN8gjmUJMf0OzDA==\" rel=\"nofollow\" target=\"_blank\">Health Canada<\/a>. The WRAPSODY CIE previously received the Conformit\u00e9 Europ\u00e9enne (CE) Mark for commercial use in the European Union and is available in Brazil.<\/p>\n<p>For more information on the WRAPSODY CIE, please visit: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rKAZJbVtzW6rfZ4DFMKdnE6mD56QRzWKWKz6vRbg4owItyxpGOGZ9AEX0ep9M2UmofK4TfmTj2eLpbF_uKVaUj1xXSq9Re_pEYcgZnwEuKvH4zd3nx24QHz4l4CkXdyx4UUuNMWSKed58FxmdNyD95m0hNxTHrVeFiMhvci4oHo=\" rel=\"nofollow\" target=\"_blank\">https:\/\/www.merit.com\/product\/wrapsody-cie\/<\/a>.<\/p>\n<p>Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit&#8217;s filings with the U. S. Securities and Exchange Commission (\u201cSEC\u201d). For discussion of the risks and uncertainties which may affect Merit\u2019s business, operations and financial condition, see Part I, Item 1A, \u201cRisk Factors\u201d in Merit\u2019s Annual Report on Form 10-K for the year ended December 31, 2024, Part II, Item 1A, \u201cRisk Factors\u201d in Merit\u2019s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and Merit\u2019s other filings with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.<\/p>\n<p>\n        <u>ABOUT MERIT <\/u><br \/>\n        <br \/>Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide.\u00a0<\/p>\n<p>\n        <u>TRADEMARKS<\/u><br \/>\n        <br \/>Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc.,\u202fits subsidiaries, or its licensors.\u00a0\u00a0<\/p>\n<p>\n        <u>CONTACTS\u00a0<\/u><br \/>\n        <br \/>PR\/Media Inquiries\u00a0<br \/>Sarah Comstock\u00a0<br \/>Merit Medical\u00a0<br \/>+1-801-432-2864 |\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=JVeZ7_J1uRQl1IYBZE4Ajqo-Q-6I6bmpZvR8ks4mFatR3beYMZ3m85fKfAyWK4DZ2aNHYWTTUU1fiBjQzrM8OC__bVQcV1zYYYNiG5GHMsIRvSgJdHzCFiaTw8sDBv5L\" rel=\"nofollow\" target=\"_blank\">sarah.comstock@merit.com<\/a>\u00a0\u00a0<\/p>\n<p>\n        <u>INVESTOR INQUIRIES<\/u>\u00a0<br \/>Mike Piccinino, CFA, IRC\u00a0<br \/>Westwicke &#8211; ICR\u00a0<br \/>+1-443-213-0509 |\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=aqlWUzTWdG8UQG66WQrmEsJVdNF25upYpJxuahdJHc9EVP9Qm67ir7e274bexUOybJSJHAqyTxXpNvhNnIvbq10evozl93H0f6_azjIL6vB6XuB1Db7hD84D8OhlfdTi\" rel=\"nofollow\" target=\"_blank\">mike.piccinino@westwicke.com<\/a>\u00a0<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUxMzA3MiM3MTAxMjM1IzIwMDg1MzY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/YzQzYmE3YWQtY2RkZS00NmE1LWE5M2QtYWZiY2E2ZTY0Yjc2LTEwMjAxMDktMjAyNS0wOC0xOC1lbg==\/tiny\/Merit-Medical-Systems-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY\u00ae Cell-Impermeable Endoprosthesis (CIE). The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN. SOUTH JORDAN, Utah, Aug. 18, 2025 (GLOBE NEWSWIRE) &#8212; Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry. The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-876682","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY\u00ae Cell-Impermeable Endoprosthesis (CIE). The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN. SOUTH JORDAN, Utah, Aug. 18, 2025 (GLOBE NEWSWIRE) &#8212; Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry. The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/","og_locale":"en_US","og_type":"article","og_title":"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry - Market Newsdesk","og_description":"The WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY\u00ae Cell-Impermeable Endoprosthesis (CIE). The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN. SOUTH JORDAN, Utah, Aug. 18, 2025 (GLOBE NEWSWIRE) &#8212; Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry. The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY &hellip; Continue reading \"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/","og_site_name":"Market Newsdesk","article_published_time":"2025-08-18T13:28:19+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUxMzA3MiM3MTAxMjM1IzIwMDg1MzY=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry","datePublished":"2025-08-18T13:28:19+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/"},"wordCount":886,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUxMzA3MiM3MTAxMjM1IzIwMDg1MzY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/first-patient-enrolled-in-merit-medicals-wrapsody-wrap-north-america-registry\/","name":"First Patient Enrolled in Merit Medical\u2019s WRAPSODY (WRAP) North America Registry - 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