PRECICE Intramedullary Limb Lengthening System De7c96d5 687e 4102 9f5f Ab9828d508ad

2017-07-07

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PRECICE intramedullary limblengthening systemExpert Rev. Med. Devices Early online, 1–19 (2015)Dror PaleyThe Paley Advanced Limb LengtheningInstitute at St. Mary’s Medical Center,901 45th Street, Kimmel Building,West Palm Beach, FL 33407, USATel.: +1 561 844 5244Fax: +1 561 844 5245drorpaley@gmail.comThe PRECICEIntramedullary Limb Lengthening System (Ellipse Technologies Inc., CA, USA) isa remotely controlled, magnetically driven, implantable limb lengthening intramedullary nailsystem. It has both CE mark and US FDA clearance for its first- (2011) and second-generation(2013) implants. It is indicated for the treatment of limb length discrepancy and short stature.It has been used worldwide in over 1000 cases. Its reported and published results in over250 cases has been excellent with less pain and lower complication rates than with externalfixation methods or previous implantable nail systems.KEYWORDS:congenital femoral deficiency .distraction osteogenesis .fibular hemimelia .intramedullary nails .leglength discrepancy .limb length discrepancy .magnet .noninvasive .PRECICEEllipse Technologies (Irvine, CA, USA) devel-oped the PRECICE nail with a team of sur-geons (including myself) headed by Dr. StuartGreen. They used the same mechanism thatthey had developed for their spinal growingrod called ‘the MAGEC System’[1]. There is amagnetic metal spindle that is connected to aseries of gears (FIGURE 1). The gears are con-nected to a coupling, which is connected to athreaded drive shaft. The mechanism is acti-vated by an external remote control (ERC)device (FIGURE 2A). The ERC employs twomotor-driven rotating magnets to magneticallycouple to and rotate the magnetic metalspindle (FIGURE 2B). Facing the ERC in onedirection causes the nail to lengthen, while fac-ing it the other direction would go in thereverse (shortening) direction. PRECICE is thesecond FDA-cleared implantable lengtheningnail device (July 2011) and the first one tohave bidirectional control (lengthening andshortening). I had the privilege of implantingthe first PRECICE nail in the USA on1 December 2011.The Ilizarov procedure remained the bestoption for limb lengthening until the intro-duction of these new nails in the 1990s. Itwas thought that with this new technologythe complications related to limb lengtheningwould be greatly diminished. Intramedullarynail techniques are not without complica-tions, which may include nonunions, nerveinjuries, nail fractures, joint contractures andother serious complications [2–10]. Externalfixation approaches to limb lengtheningremain the gold standard. Experience withimplantable limb lengthening have made evi-dent that the complications of limb lengthen-ing can be divided into two categories, devicerelated and distraction related. The device-related complications are very different forexternal versus internal lengthening devices.The high complication rates related to pintract infections, joint stiffness and contrac-tures due to tethering of the muscles by thepins, and large pin tract scars, do not occurwith implantable devices. The complicationsrelated to distraction are similar betweenexternal and internal lengthening methods.These complications include premature con-solidation, delayed and failed bone formation,nerve stretch injury, muscle contractures andjoint subluxation. The reduced device compli-cations and even some reduced distractioncomplications (e.g., axial deviation) havemade the switch to implantable devices veryattractive and have created a market for thesetechnologically advanced devices.Body of reviewOverview of the marketThe indications for limb lengthening are forthe treatment of limb length discrepancy ofthe lower or upper limb and for staturelengthening. The indications for leg lengthen-ing are for the treatment of leg length dis-crepancy or short stature. Unilateral limblengthening is used to equalize limb length ininformahealthcare.com 10.1586/17434440.2015.1005604 2015 Informa UK Ltd ISSN 1743-4440 1Device ProfileExpert Review of Medical Devices Downloaded from informahealthcare.com by 73.46.221.27 on 02/18/15For personal use only.

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