{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T13:43:12Z","timestamp":1790516592845,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2012,9,28]],"date-time":"2012-09-28T00:00:00Z","timestamp":1348790400000},"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":[[2013,2]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic\u2010coated double\u2010disc patent foramen ovale (PFO) occluder.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider\u2122 PFO occluder was designed to minimize these risks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Spider\u2122 PFO occluder is a self\u2010expandable double\u2010disc device with a ceramic coated nitinol wire mesh and an integrated expanded polytetrafluoroethylene (ePTFE) membrane on the right atrial side and ceramic coated nitinol anchors and ePTFE patch on the left atrial side. Study patient assessments were conducted at baseline, periprocedure, and discharge and at 1\u2010, 6\u2010 and 12\u2010month follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010one patients (mean age 52 \u00b1 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 \u00b1 8.6 min. No periprocedural or in\u2010hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1\u2010month follow\u2010up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1\u2010month follow\u2010up 63% (32\/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6\u2010month echo follow\u2010up to date, 78% (39\/50) had no residual shunt during Valsalva maneuver.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Initial results with the novel Spider\u2122 PFO occluder show that the device is safe and easy to use for percutaneous closure of PFO. The overall complication rate was low. The rate of AF needs further investigation. \u00a9 2012 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.24584","type":"journal-article","created":{"date-parts":[[2012,8,6]],"date-time":"2012-08-06T10:33:03Z","timestamp":1344249183000},"page":"317-323","source":"Crossref","is-referenced-by-count":6,"title":["Safety and performance of the spider\u2122 patent foramen ovale occluder"],"prefix":"10.1002","volume":"81","author":[{"given":"Tina","family":"Edwards\u2010Lehr","sequence":"first","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Franke","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan C.","family":"Bertog","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"B\u00e4cker","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Wunderlich","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilona","family":"Hofmann","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Wilson","sequence":"additional","affiliation":[{"name":"John Radcliffe Hospital Oxford Oxford United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Fran\u00e7ois","family":"Piechaud","sequence":"additional","affiliation":[{"name":"Jacques Cartier\u2010ICPS in Massy France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horst","family":"Sievert","sequence":"additional","affiliation":[{"name":"CardioVascular Center Frankfurt Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,9,28]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2003.10.030"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.20427"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2009.05.044"},{"key":"e_1_2_6_5_1","unstructured":"EricZi.Cera Occluders. Presented at Congress of the European Association of Percutaneous Cardiovascular Intervention May 19 2009 Barcelona Spain."},{"key":"e_1_2_6_6_1","first-page":"834","article-title":"Transcatheter closure of patent foramen ovale with the Spider patent foramen ovale occluder: A prospective, single\u2010center trial","volume":"123","author":"Zhang CJ","year":"2010","journal-title":"Chin Med J (Engl)"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01904-6"},{"key":"e_1_2_6_8_1","volume-title":"A prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with a stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale. 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