The FDA has given Ellipse Technologies (Irvine, CA) clearance to bring to market the company’s PRECICE 2 limb lengthening system. The PRECICE system features a non-invasive mechanism for adjusting the length of the implant that relies on a magnet inside the device and an external remote controller that activates it. The system is indicated for lengthening the tibia and femur bones of the legs either following an injury or for those with congenital conditions.
The new PRECICE 2 system improves on some of the characteristics of the original version, including allowing for a greater range of lengthening and a new narrower and longer nail that is compatible with more patient anatomies.
From the announcement:
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.”