Magnetic mini-mover procedure for pectus excavatum III: Safety and efficacy in a food and drug administration-sponsored clinical trial

Michael R. Harrison, Kelly D. Gonzales, Barbara J. Bratton, Darrell Christensen, Patrick F. Curran, Richard Fechter, Shinjiro Hirose

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Purpose: The magnetic mini-mover procedure (3MP) uses magnetic force to gradually remodel pectus excavatum deformity. A magnet is implanted on the sternum and coupled with an external magnetic brace. Under Investigational Device Exemption and Institutional Review Board approval, we performed a pilot study of safety, probable efficacy, and cost-effectiveness of this new treatment of an orphan disease using an implantable pediatric device. Methods: Ten otherwise healthy patients, ages 8 to 14 years, with severe pectus excavatum (pectus severity index [PSI] > 3.5) underwent 3MP treatment (mean, 18.8 ± 2.5 months). Safety was assessed by postimplant and postexplant electrocardiograms and monthly chest x-rays. Efficacy was assessed by change in pectus severity index as measured using pretreatment and posttreatment computed tomographic scan. Cost of 3MP was compared with that of standard procedures. Results: The 3MP device had no detectable ill effect. Device weld failure or malpositioning required revision in 5 patients. Average wear time was 16 h/d. Pectus severity index improved in patients in the early or mid puberty but not in patients with noncompliant chest walls. Average cost for 3MP was $46,859, compared with $81,206 and $81,022 for Nuss and Ravitch, respectively. Conclusion: The 3MP is a safe, cost-effective, outpatient alternative treatment for pectus excavatum that achieves good results for patients in early and midpuberty stages.

Original languageEnglish (US)
Pages (from-to)154-159
Number of pages6
JournalJournal of Pediatric Surgery
Volume47
Issue number1
DOIs
StatePublished - Jan 1 2012

Keywords

  • Chest wall deformity
  • Magnetic Mini-Mover
  • Pectus excavatum
  • Pediatric device
  • Sunken chest

ASJC Scopus subject areas

  • Surgery
  • Pediatrics, Perinatology, and Child Health

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