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Pediatric and congenital electrophysiology society initiative on device needs in pediatric electrophysiology

Published:December 20, 2018DOI:https://doi.org/10.1016/j.hrthm.2018.12.021
      There are few cardiovascular devices approved in children (Table 1), with only 5 devices approved for use in the pediatric electrophysiology patient in the last 10 years. This lack of appropriate pediatric-tested technology has resulted in a high rate of off-label device utilization in children.
      • Dolcimascolo F.
      Pediatric cardiac devices—an FDA pediatrician's perspective of the challenges and potential solutions.
      Sutherell et al
      • Sutherell J.S.
      • Hirsch R.
      • Beekman R.H.
      Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices.
      found an off-label use of an approved device in 63% of patients treated in an interventional pediatric cardiology program.
      Table 1Cardiovascular medical devices approved by the FDA for pediatric application 2008–2018
      Device Generic description Year Mechanism of approval
      NeuRX RA/4 Respiratory Stimulation System Diaphragm pacing stimulator 2008 HDE
      Helios II Diagnostic Ablation Catheter Cardiac ablation catheter 2009 PMA
      Repel-CV Bioresorbable Adhesion Barrier Bioresorbable adhesion barrier 2009 PMA
      Melody Transcatheter Pulmonary Valve and Medtronic Ensemble Transcatheter Valve and Delivery System Prosthetic percutaneous pulmonary valve 2010 HDE
      RX Acculink Carotid Stent System Carotid stent 2011 PMA
      Medtronic Vascular Endurant Stent Graft System Endovascular stent 2011 PMA
      Valiant Thoracic Stent Graft System Endovascular stent 2011 PMA
      RX Herculink Elite Renal Stent System Renal stent 2011 PMA
      Legoo Temporary vessel occluder 2011 PMA
      TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Drug-eluting coronary stent system 2012 PMA
      AXUS Liberte Paclitaxel-Eluting Coronary Stent System Drug-eluting coronary stent system 2012 PMA
      ION Paclitaxel-Eluting Coronary Stent System Drug-eluting coronary stent system 2012 PMA
      Berlin Heart EXCOR Pediatric Ventricular Assist Device Ventricular assist device 2012 HDE
      VALIANT THORACIC STENT GRAFT Endovascular graft 2013 PMA
      Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System Percutaneous pulmonary valve 2015 PMA
      Impella RP System Right ventricular assist device 2016 HDE
      LifeVest Wearable Defibrillator Wearable defibrillator 2016 PMA
      The Edwards SAPIEN XT Transcatheter Heart Valve (THV) Percutaneous aortic valve 2016 PMA
      Blazer Open-Irrigated Ablation Catheter Cardiac ablation catheter 2016 PMA
      EXCOR Pediatric Ventricular Assist Device Ventricular assist device 2017 PMA
      AED Plus—Zoll Defibrillator 2017 PMA
      HeartSine Samaritan PAD 350P Defibrillator 2017 PMA
      Melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Valve Delivery System Transcatheter pulmonary valve 2017 PMA
      AMPLATZER PFO Occluder Percutaneous PFO occluder 2017 PMA
      Bold indicates EP/arrhythmia devices.
      HDE = humanitarian device exemption; PFO = patent foramen ovale; PMA = premarket approval.
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