Magnetic Mini-Mover Procedure for pectus excavatum IV: FDA sponsored multicenter trial.

Purpose: The Magnetic Mini-Mover Procedure (3MP) is a minimally invasive treatment for prepubertal patients with pectus excavatum. This multicenter trial sought to supplement safety and efficacy data from an earlier pilot trial.

Methods: Fifteen patients with pectus excavatum had a titanium-enclosed magnet implanted on the sternum.

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

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.

Magnetic mini-mover procedure for pectus excavatum II: initial findings of a Food and Drug Administration-sponsored trial.

Purpose: The Magnetic Mini-Mover Procedure (3MP) uses a magnetic implant coupled with an external magnet to generate force sufficient to gradually remodel pectus excavatum deformities. This is an interim report of the evolution of the 3MP during a Food and Drug Administration-approved clinical trial.

Methods: After obtaining Institutional Review Board approval, we performed the 3MP on 10 otherwise healthy patients with moderate to severe pectus excavatum deformities (age, 8-14 years; Haller index >3.

Magnetic Mini-Mover Procedure for pectus excavatum: I. Development, design, and simulations for feasibility and safety.

Background/purpose: Correction of pectus excavatum (PE) results in measurable improvement in lung capacity and cardiac performance as well as improved appearance and self-image. The Nuss and modified Ravitch approaches attempt to correct the chest wall deformity by forcing the sternum forward in 1 step and holding it in place using a metal strut. The initial operation requires extensive manipulation under general anesthesia and results in postoperative pain, requiring hospitalization and regional anesthesia.