FDA Clears Limb Lengthening System from Ellipse Technologies

The U.S. Food and Drug Administration (FDA) has cleared limb-lengthening technology from Irvine, Calif.-based Ellipse Technologies Inc.

The FDA cleared the Precice 2 intramedullary limb lengthening system in the United States, which is an updated version of the first iteration of the first Precice system cleared in 2011.

The system allows precisely controlled, non-invasive adjustment of the implant that the company claims is “unavailable with other treatment options.”

To date, Precice devices have been used in more than 700 procedures in 12 countries by more than 100 surgeons, the company reports.

The second-generation Precice 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, company officials noted. The new system also includes a new smaller diameter (8.5 millimeter) nail which will address a large segment of patients whose anatomy was too small for the original, larger nail devices.

“The introduction of the Precice 2 system complements the early success of the Precice device
with improved efficiency in the operating room 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.”

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, Fla., were the first surgeons in the United States to use Precice 2.

“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 Standard.

Paley said the system makes a “great device even better,” allowing him to treat a wider spectrum of patients.

The FDA’s clearance is for limb lengthening of the femur or tibia, and the system can be used to correct limb inequality caused by congenital shortening, post-traumatic fractures, and other conditions that result in leg shortening.

Ellipse Technologies is focused on orthopedic and spinal applications of its technology.