title: Safety and performance of the Spider™ patent foramen ovale occluder.
abstract: OBJECTIVE
  The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic-coated double-disc patent foramen ovale (PFO) occluder.
  
  
  BACKGROUND
  Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider™ PFO occluder was designed to minimize these risks.
  
  
  METHODS
  The Spider™ PFO occluder is a self-expandable double-disc 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-, 6- and 12-month follow-up.
  
  
  RESULTS
  Fifty-one patients (mean age 52 ± 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 ± 8.6 min. No periprocedural or in-hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1-month follow-up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1-month follow-up 63% (32/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6-month echo follow-up to date, 78% (39/50) had no residual shunt during Valsalva maneuver.
  
  
  CONCLUSIONS
  Initial results with the novel Spider™ 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.
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Tina
authors.initials: T
authors.lastname: Edwards-Lehr
authors.forename: Jennifer
authors.initials: J
authors.lastname: Franke
authors.forename: Stefan C
authors.initials: SC
authors.lastname: Bertog
authors.forename: Christina
authors.initials: C
authors.lastname: Bäcker
authors.forename: Nina
authors.initials: N
authors.lastname: Wunderlich
authors.forename: Ilona
authors.initials: I
authors.lastname: Hofmann
authors.forename: Neil
authors.initials: N
authors.lastname: Wilson
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Piechaud
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000328:Adult; D000368:Aged; D000497:Alloys; D001281:Atrial Fibrillation / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002516:Ceramics; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017548:Echocardiography, Transesophageal; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D005602:France; D005858:Germany; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D014636:Valsalva Maneuver
chemical_list: D000497:Alloys; D020099:Coated Materials, Biocompatible; C013616:nitinol; D011138:Polytetrafluoroethylene