Johnson & Johnson’s (NYSE:JNJ) newly formed DePuy Synthes Spine division came out of the gates swinging, announcing its 1st regulatory win less than a month after closing the books on the $19.7 billion merger.
DePuy Synthes Spine this week announced expanded FDA clearance for its Expedium, Viper and Viper2 spine systems for adolescents with idiopathic scoliosis, a condition resulting in abnormal curvature of the spine, typically in children between the ages of 10 and 18. The devices were already cleared for adults.
"This FDA clearance is an important milestone for us as a company, and is also important for adolescent patients who will have greater access to the latest technology available if they require spine surgery for their scoliosis," DePuy Synthes worldwide president Namal Nawana said in prepared remarks.
It’s the 1st joint move for the company, which was born when Johnson & Johnson folded Synthes into its DePuy business last month.
U.S. regulators approved the merger on after getting a guarantee that Johnson & Johnson would ditch some of its DePuy orthopedics properties. EuroZone regulators approved the merger in April.
The deal, the largest in J&J’s history, was initially confirmed in April 2011 as the healthcare giant was facing a 23% drop in quarterly profits. The merger is expected to change the orthopedics landscape; J&J hopes it will revive its troubled DePuy brand, which is in the midst of a controversial recall regarding metal-on-metal hip implants that fail more frequently expected from clinical trials and may expose patients to toxic chemicals as they erode.
JNJ shares closed 1% higher at $69.12 today.
