title: Initial clinical experience with the Coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: results of the Coherex-EU study.
abstract: OBJECTIVE
  The Coherex-EU Study evaluated the safety and efficacy of PFO closure utilizing novel in-tunnel PFO closure devices.
  
  
  BACKGROUND
  Transcatheter closure of patent foramen ovale (PFO) followed the development of transcatheter closure devices designed to patch atrial septal defects (ASDs). The Coherex FlatStent™ and FlatStent™ EF devices were designed specifically to treat PFO anatomy.
  
  
  METHODS
  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-six patients received the first-generation FlatStent study device, and 57 patients received the second-generation 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.
  
  
  RESULTS
  At 6 months post-procedure, 45% (17/38) of the intention-to-treat (ITT) cohort receiving the first-generation 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-generation 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.
  
  
  CONCLUSIONS
  This initial study of the Coherex FlatStent/FlatStent EF PFO Closure System demonstrated the potential for in-tunnel PFO closure. The in-tunnel 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.
authors: Johann Wolfgang Goethe University, Frankfurt, Germany; Katharinen Hospital, Stuttgart, Germany; Cardiovascular Center, Frankfurt, Germany; Sankt Katharinen Hospital, Frankfurt, Germany; Department Internal Medicine, Cardiology and Vascular Medicine, St. Josefs-Hospital, Wiesbaden, Germany.
authors: Horst
authors: H
authors: Sievert
authors: Nina
authors: N
authors: Wunderlich
authors: Isabel
authors: I
authors: Reiffenstein
authors: Peter
authors: P
authors: Ruygrok
authors: Eberhard
authors: E
authors: Grube
authors: Lutz
authors: L
authors: Buellesfeld
authors: Bernhard
authors: B
authors: Meier
authors: Joachim
authors: J
authors: Schofer
authors: David
authors: D
authors: Muller
authors: Randall K
authors: RK
authors: Jones
authors: Linda
authors: L
authors: Gillam
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000379:methods*; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D055989:Septal Occluder Device; D015607:Stents; D016896:Treatment Outcome; D055815:Young Adult