Treace Medical Concepts Inc. announced it received FDA clearance to expand indications of its Lapiplasty 3-D Bunion Correction System to treat pediatric patients 12 years of age and older, according to a company press release.
According to the release, system is intended to correct all three dimensions of the bunion deformity, secure the unstable joint in the middle of the foot and get patients back on their feet quickly after surgery.
“This is exciting news for bunion patients and further demonstrates our commitment to improving outcomes across the full spectrum of patients suffering from this painful and activity-limiting deformity” John T. Treace, CEO of Treace Medical, said in the release. “Traditional osteotomy surgery has been associated with a high rate of recurrence, thus presenting a unique concern for younger patients. The Lapiplasty procedure has clinically demonstrated high success rates in adults, and we believe this expanded indication will provide an important new treatment option for pediatric patients seeking a more comprehensive and lasting correction of their bunion.”