title: Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.
abstract: OBJECTIVE
  This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC).
  
  
  BACKGROUND
  The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system.
  
  
  METHODS
  Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total).
  
  
  RESULTS
  The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%).
  
  
  CONCLUSIONS
  Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC.
authors.affiliation: Division of Cardiology, Rady Children's Hospital, University of California, San Diego School of Medicine, San Diego, California. Electronic address: jmoore@rchsd.org.
authors.forename: John W
authors.initials: JW
authors.lastname: Moore
authors.affiliation: PFM Medical, Inc., Carlsbad, California.
authors.forename: Jessica
authors.initials: J
authors.lastname: Greene
authors.affiliation: PFM Medical, Inc., Carlsbad, California.
authors.forename: Salvadore
authors.initials: S
authors.lastname: Palomares
authors.affiliation: Division of Cardiology, Advocate Children's Hospital, University of Illinois School of Medicine, Park Ridge, Illinois.
authors.forename: Alexander
authors.initials: A
authors.lastname: Javois
authors.affiliation: Division of Cardiology, Children's Hospital Central California, Fresno, California.
authors.forename: Carl Y
authors.initials: CY
authors.lastname: Owada
authors.affiliation: Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus, Ohio.
authors.forename: John P
authors.initials: JP
authors.lastname: Cheatham
authors.affiliation: Division of Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Hoyer
authors.affiliation: Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, Washington.
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Jones
authors.affiliation: Division of Cardiology, Mattel Children's Hospital UCLA, David Geffen School of Medicine, University of California, Los Angeles, California.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Levi
mesh_terms: D000293:Adolescent; D000497:Alloys; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D004374:Ductus Arteriosus, Patent / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000497:Alloys; C013616:nitinol
keywords: coil; occluder device; patent ductus arteriosus