3Spine Inc. has announced FDA investigational device exemption approval for a clinical trial on the BalancedBack, a total joint replacement for the lumbar spine, according to a press release.
The BalancedBack total joint replacement is indicated for reconstruction and stabilization of a spinal motion segment following decompression for skeletally mature patients with symptomatic lumbar degeneration, according to the release.
“Breakthrough device designation was critical to our success in the investigational device exemption (IDE) approval process,” Ron Yarbrough, chief operating officer of 3Spine, said in the release. “This project is the culmination of decades of technical and clinical research in the lumbar spine, and while the courage of pioneering patients and surgeons brought us to this point, today it is all about the tenacity and expertise of the FDA review team. Our interactive review with FDA over the past 2 years has resulted in comprehensive coverage of an unparalleled number of technical disciplines, reflecting the potentially transformational nature of this spine technology. We are excited to begin IDE enrollment,” Yarbrough added.