December 8, 2014 by Val Kennedy
Johnson & Johnson’s DePuy Synthes Spine unit wins an FDA nod for a titanium rod device for the treatment of a rare congenital condition known as thoracic insufficiency syndrome.
Johnson & Johnson‘s (NYSE:JNJ) DePuy Synthes Spine unit has won U.S. regulatory approval for a titanium rod device for the treatment of a rare congenital condition known as thoracic insufficiency syndrome.
The FDA awarded 510(k) market clearance for DePuy’s vertical expandable prosthetic titanium rib devices for TIS, which can cause severe deformities of the spine, chest or ribs. The devices were previously available to doctors through a humanitarian device exemption from the federal watchdog agency.
The prosthetic ribs are used to help promote normal spinal growth and lung development, and can also be used to improve breathing by creating more space in the rib cage, according to a press release. The ribs can be expanded as a child grows through minimally invasive procedures.
“We are pleased with the FDA’s clearance and the resulting change in regulatory status of the VEPTR/VEPTR II devices so that more children may benefit from treatment for TIS, a condition where few treatment options exist,” DePuy Synthes Spine president Max Reinhardt said in prepared remarks. “The device fills a critical need and offers hope for a brighter future for many children.”