IRVINE, Calif.–(BUSINESS WIRE)–Ellipse Technologies, Inc. (“Ellipse”) announced today that it has received CE-Mark approval of the Company’s PRECICETM Limb Lengthening device. Limb Lengthening procedures are used to treat a number of medical conditions, including shortened legs due to congenital abnormalities, major fractures of one of the legs and shortened leg bones due to other medical diseases, such as cancer.
“The PRECICE Technology will make it possible to use externally controllable implants for patients who require bone lengthening. In the future, this technology will likely be adapted to many other orthopedic applications.”
The PRECICE devices are unique intramedullary rods which provide physicians with a new method of treating these conditions. Rather than using adjustable external fixation systems which are attached to the leg bone through long-term openings in the skin, the Ellipse device uses the PRECICE REMOTE CONTROL TECHNOLOGY, an internal implant adjusted to lengthen the leg bones via non-invasive methods from outside the body. Ellipse and its scientific advisors believe the PRECICE devices will not only provide a less-invasive approach to these procedures but also significantly reduce the potential for complications (e.g., infections) during the healing period.
Commenting on the PRECICE technology, Stuart Green, M.D., Professor of Orthopedic Surgery, University of California, Irvine said, “The PRECICE Technology will make it possible to use externally controllable implants for patients who require bone lengthening. In the future, this technology will likely be adapted to many other orthopedic applications.”
Ellipse will complete a multi-center international clinical study using the PRECICE devices by mid-2011. An international product launch in countries that accept CE-Mark approval will be implemented during the second half of 2011. Ellipse is continuing to develop additional PRECICE devices for other orthopedic fracture management applications.
MAGECTM Remote Control Spinal Deformity System
Ellipse has developed the MAGECTM Remote Control System for spinal deformity and has completed enrollment in a first-in-man clinical study following CE-Mark approval in late 2009. The MAGEC System provides a minimally invasive implant to treat spinal deformity, which can then be adjusted via remote control non-invasively. In early clinical use in childhood spinal deformity patients, the MAGEC System has provided excellent clinical results, while significantly reducing the number of surgeries in these young patients. Rather than exposing these patients to the multiple invasive surgeries required when using conventional techniques, the MAGEC System allows the physician to adjust and lengthen the spine on an out-patient basis with all follow-up procedures being conducted non-invasively by remote control in the physician’s office.
Ellipse will begin marketing the MAGEC System in European countries during the first quarter 2011.
Ellipse Technologies, Inc. is a privately-held medical device company located in Irvine, California. The Company is focused on developing its implantable remote control technology platforms to include innovative and state-of-the-art treatments for a broad spectrum of spinal and orthopedic deformity applications, orthopedic trauma and fracture management.
The PRECICETM System is not currently available for distribution in U.S.
The MAGECTM System is not currently available for distribution in U.S.