Document Detail


Initial clinical experience with the coherex FlatStent™ and FlatStent™ EF PFO closure system for in-tunnel PFO closure: Results of the Coherex-EU study.
MedLine Citation:
PMID:  22815250     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 six 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. CONCLUSION: 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. © 2012 Wiley Periodicals, Inc.
Authors:
Horst Sievert; Nina Wunderlich; Isabel Reiffenstein; Peter Ruygrok; Eberhard Grube; Lutz Buellesfeld; Bernhard Meier; Joachim Schofer; David Muller; Randall K Jones; Linda Gillam
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-19
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  -     ISSN:  1522-726X     ISO Abbreviation:  -     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-7-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Affiliation:
Professor of Internal Medicine/Cardiology/Vascular Medicine at Johann Wolfgang Goethe University Frankfurt; Cardiovascular Associates at Katharinen Hospital; Director Cardiovascular Center Frankfurt, Sankt Katharinen Hospital; Director, Department Internal Medicine, Cardiology and Vascular Medicine; Senior Consultant St. Josefs-Hospital, Wiesbaden, Germany. HorstSievertMD@aol.com.
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