{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T19:40:47Z","timestamp":1792179647888,"version":"4.4.0"},"reference-count":7,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,12,3]],"date-time":"2018-12-03T00:00:00Z","timestamp":1543795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To report the results of the Nit\u2010Occlud PDA prospective postapproval study (PAS) along with a comparison to the results of the pivotal and continued access trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The Nit\u2010Occlud PDA (PFM Medical, Cologne, Germany), a nitinol coil patent ductus arteriosus (PDA) occluder, was approved by the Food and Drug Administration in 2013.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The PAS enrolled a total of 184 subjects greater than 6\u2009months of age, weighing at least 5\u2009kg, with PDAs less than 4 mm by angiography at 11 centers. Patients were followed prospectively at 2 months, 12\u2009months, and 24\u2009months postprocedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols. Efficacy and safety data were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 184 subjects enrolled for the PAS between 2014 and 2017, 180 (97.8%) had successful device implantation. After 12\u2009months, 98.7% (150\/152) had trivial or no residual shunt by echocardiography and two subjects had only small residual shunts. There were three device embolizations that were all retrieved by snare without clinical consequence. Together with the pivotal and continued access study, 97.4% (449\/461) had complete echocardiographic closure at 12\u2009months in 541 enrolled subjects. The composite success was 94.4%. There were no mortalities and no serious device\u2010related adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Nit\u2010Occlud PDA is a safe and effective device for closure of a small to moderate sized PDA. There were no serious device\u2010related adverse events in a large cohort of three clinical trials.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27995","type":"journal-article","created":{"date-parts":[[2018,12,4]],"date-time":"2018-12-04T05:44:00Z","timestamp":1543902240000},"page":"645-651","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Results of the combined U.S. multicenter postapproval study of the Nit\u2010Occlud PDA device for percutaneous closure of patent ductus arteriosus"],"prefix":"10.1002","volume":"93","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4682-0309","authenticated-orcid":false,"given":"Daisuke","family":"Kobayashi","sequence":"first","affiliation":[{"name":"Division of Cardiology, Children's Hospital of Michigan Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine  Detroit Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morris M.","family":"Salem","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Cardiology Kaiser Permanente  Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J.","family":"Forbes","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Children's Hospital of Michigan Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine  Detroit Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent M.","family":"Gordon","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Loma Linda University Children's Hospital  Loma Linda California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian D.","family":"Soriano","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Seattle Children's Hospital  Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Dimas","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics University of Texas Southwestern Medical Center, Children's Health System of Texas  Dallas Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan H.","family":"Goldstein","sequence":"additional","affiliation":[{"name":"The Heart Institute, Cincinnati Children's Hospital Medical Center University of Cincinnati College of Medicine  Cincinnati Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl","family":"Owada","sequence":"additional","affiliation":[{"name":"Valley Children's Hospital  Madera California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Javois","sequence":"additional","affiliation":[{"name":"Division of Cardiology Advocate Children's Hospital, University of Illinois School of Medicine  Oak Lawn Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Bass","sequence":"additional","affiliation":[{"name":"University of Minnesota Masonic Children's Hospital  Minneapolis Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas K.","family":"Jones","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology Seattle Children's Hospital  Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren P.","family":"Berman","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Nationwide Children's Hospital The Ohio State University  Columbus Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Cardiac Center Children's Hospital of Philadelphia  Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Moore","sequence":"additional","affiliation":[{"name":"Division of Cardiology Rady Children's Hospital, University of California, San Diego School of Medicine  San Diego California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel S.","family":"Levi","sequence":"additional","affiliation":[{"name":"Division of Cardiology Mattel Children's Hospital at University of California Los Angeles  Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,12,3]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31821b1f10"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.06.019"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/1522-726X(200011)51:3<293::AID-CCD10>3.0.CO;2-V"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9149(89)90064-7"},{"key":"e_1_2_8_6_1","volume-title":"Instructions for Use \u2013 Amplatzer Duct Occluder and Delivery System","author":"St. Jude Medical","year":"2014"},{"key":"e_1_2_8_7_1","volume-title":"Instructions for Use \u2013 Amplatzer Duct Occluder II","author":"St. Jude Medical","year":"2013"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.09.045"}],"container-title":["Catheterization and Cardiovascular 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