Magnetic mini-mover procedure for pectus excavatum III: safety and efficacy in a Food and Drug Administration-sponsored clinical trial.

Published

Journal Article

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.

Full Text

Cited Authors

  • Harrison, MR; Gonzales, KD; Bratton, BJ; Christensen, D; Curran, PF; Fechter, R; Hirose, S

Published Date

  • January 2012

Published In

Volume / Issue

  • 47 / 1

Start / End Page

  • 154 - 159

PubMed ID

  • 22244409

Pubmed Central ID

  • 22244409

Electronic International Standard Serial Number (EISSN)

  • 1531-5037

International Standard Serial Number (ISSN)

  • 0022-3468

Digital Object Identifier (DOI)

  • 10.1016/j.jpedsurg.2011.10.039

Language

  • eng