{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T04:37:24Z","timestamp":1773031044831,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,11,27]],"date-time":"2013-11-27T00:00:00Z","timestamp":1385510400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2014,6]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The Coherex\u2010EU Study evaluated the safety and efficacy of PFO closure utilizing novel in\u2010tunnel PFO closure devices.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent\u2122 and FlatStent\u2122 EF devices were designed specifically to treat PFO anatomy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 95 patients with a clinical indication for PFO closure were enrolled in a prospective, multicenter first in man study at six clinical sites. Thirty\u2010six patients received the first\u2010generation FlatStent study device, and 57 patients received the second\u2010generation FlatStent EF study device, which was modified based on clinical experience during the first 38 cases. Two patients enrolled to receive the first generation did not receive a device.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At 6 months post\u2010procedure, 45% (17\/38) of the intention\u2010to\u2010treat (ITT) cohort receiving the first\u2010generation FlatStent device had complete closure, 26% (10\/38) had a trivial residual shunt, and 29% (11\/38) had a moderate to large residual shunt. In the ITT cohort receiving the second\u2010generation FlatStent EF device, 76% (43\/57) had complete closure, 12% (7\/57) had a trivial shunt, and 12% had a moderate to large shunt. Five major adverse events occurred, all without sequelae.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This initial study of the Coherex FlatStent\/FlatStent EF PFO Closure System demonstrated the potential for in\u2010tunnel PFO closure. The in\u2010tunnel Coherex FlatStent EF may offer an alternative to septal repair devices for PFO closure in appropriately selected patients; however, further investigation will be necessary to establish the best use of this device. \u00a9 2012 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.24565","type":"journal-article","created":{"date-parts":[[2012,7,20]],"date-time":"2012-07-20T20:05:37Z","timestamp":1342814737000},"page":"1135-1143","source":"Crossref","is-referenced-by-count":10,"title":["Initial clinical experience with the Coherex FlatStent\u2122 and FlatStent\u2122 EF PFO closure system for in\u2010tunnel PFO closure: Results of the Coherex\u2010EU study"],"prefix":"10.1002","volume":"83","author":[{"given":"Horst","family":"Sievert","sequence":"first","affiliation":[{"name":"Johann Wolfgang Goethe University Frankfurt Germany"},{"name":"Katharinen Hospital Stuttgart Germany"},{"name":"Cardiovascular Center Frankfurt Germany"},{"name":"Sankt Katharinen Hospital Frankfurt Germany"},{"name":"Department Internal Medicine, Cardiology and Vascular Medicine St. Josefs\u2010Hospital Wiesbaden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Wunderlich","sequence":"additional","affiliation":[{"name":"Cardiovascular Center Frankfurt Germany"},{"name":"Sankt Katharinen Hospital Frankfurt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabel","family":"Reiffenstein","sequence":"additional","affiliation":[{"name":"Cardiovascular Center Frankfurt Germany"},{"name":"Sankt Katharinen Hospital Frankfurt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Ruygrok","sequence":"additional","affiliation":[{"name":"Green Lane Cardiovascular Service Auckland District Health Board Auckland City Hospital Auckland New Zealand"},{"name":"Middlemore Hospital Papatoetoe Auckland New Zealand"},{"name":"Auckland Heart Group &amp; Mercy Hospital Auckland New Zealand"},{"name":"University of Auckland Auckland New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eberhard","family":"Grube","sequence":"additional","affiliation":[{"name":"Department of Cardiology\/Angiology Heart Center Siegburg Siegburg Germany"},{"name":"Medical School University of Bonn Bonn Germany"},{"name":"Division of Cardiovascular Medicine Stanford University School of Medicine Stanford California"},{"name":"Department of Cardiology Hospital Israelita Albert Einstein Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lutz","family":"Buellesfeld","sequence":"additional","affiliation":[{"name":"Department of Cardiology Swiss Cardiovascular Center Bern University of Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhard","family":"Meier","sequence":"additional","affiliation":[{"name":"Department of Cardiology Swiss Cardiovascular Center Bern University of Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joachim","family":"Schofer","sequence":"additional","affiliation":[{"name":"Hamburg University Cardiovascular Center Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Muller","sequence":"additional","affiliation":[{"name":"University of New South Wales Cardiac Catheterization Laboratories St Vincent's Hospital Sydney Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randall K.","family":"Jones","sequence":"additional","affiliation":[{"name":"Coherex Medical, Inc. Salt Lake City Utah"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Gillam","sequence":"additional","affiliation":[{"name":"Division of Cardiology Columbia University College of Physicians and Surgeons New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,11,27]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.86.6.1902"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199508243330801"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2001.tb00745.x"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-6196(12)60336-X"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-8703(95)90212-0"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.10.055"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccl.2004.10.003"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2004.12.026"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8183.2005.00072.x"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.24.2954"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.2143\/AC.60.5.2004973"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.2007.118505"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2008.02.031"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003643-199905000-00013"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(88)92944-3"},{"issue":"3","key":"e_1_2_6_17_1","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1002\/ccd.21809","article-title":"Pi\u00e9chaud. 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