Next Generation of Magnetic Limb Lengthening System Gets FDA Clearance

Last week we reported the news that the UK’s NICE agency had issued a guidance document relating to Ellipse Technologies’ Magec®, magnetically controlled scoliosis device. Now the company has received U.S. FDA marketing clearance of the Precice® 2 Intramedullary Limb Lengthening System, based on the same principle of non-invasive adjustment.

Background

The innovative Precice system was originally cleared for use in the U.S. in 2011. In essence it allows precisely controlled, non-invasive adjustment of an implanted device, in so doing avoiding the need for multiple invasive procedures. It is ideally suited to procedures such as limb lengthening where the concept of numerous millimetric adjustments provide the gradual distraction required to establish desired limb length. Ellipse says Precice devices have been used in over 700 procedures in 12 countries by more than 100 surgeons. Its initial success has confirmed it as the preferred treatment option for patients with limb length inequality.

The new Precice 2 system introduces a non-modular intramedullary design to simplify its implantation and provides increased nail length and distraction range options to better optimize treatment options. This system also includes a new smaller diameter (8.5 mm) nail, which will address a large segment of patients whose anatomy was too small for the original, larger Precice nail devices.

Physician comments

Surgeons Shawn C. Standard, M.D., Head of Pediatric Orthopedics at the International Center for Limb Lengthening at Sinai Hospital in Baltimore, MD, and Dror Paley, M.D., Director of the Paley Advanced Limb Lengthening Institute at St. Mary’s Medical Center in West Palm Beach, FL, were the first surgeons in the U.S. to use the Precice 2 system.

“Previously, treatment options for patients with limb length inequality were very limited. The Precice system has dramatically impacted my practice over the last two years, and, with Precice 2, I expect even better results for my patients.” said Dr. Standard. Dr. Paley added, “The Precice 2 system makes a great device even better and allows me to treat a wider spectrum of patients than before.”

Company comments

“The introduction of the Precice 2 system complements the early success of the Precice device with improved efficiency in the OR and the larger range of patients with limb length inequality who can now be treated,” said Ed Roschak, President and CEO of Ellipse. “We continue to work every day to apply our platform technology to address unmet needs in orthopedics and spine.”

Source: Ellipse Technologies, Inc., Marketwired

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