Healthcare company Zimmer Biomet Holdings Inc (NYSE:ZBH) (SIX:ZBH) revealed on Friday the receipt of approval from the US Food and Drug Administration approval for The Tether for the fusion-less alternative surgery in young patients with scoliosis requiring surgery.
According to the company, the current surgical treatment for scoliosis is an invasive operation involving large incisions, extensive soft tissue disruption and restriction of spinal motion with metal rods inserted along both sides of the spine to secure and align the vertebrae.
The Tether, the company's anterior vertebral body tethering (AVBT) solution, uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow. Additionally, unlike fusion metallic rods, The Tether is positioned utilizing an endoscopic minimally invasive approach through a few small openings between the ribs.
In conjunction, The Tether is available through the US FDA's humanitarian device exemption (HDE) pathway.
Under a collaboration with the US FDA and the Harms Study Group, a worldwide cohort of surgeons, the company will launch and perform a comprehensive, multi-centre, prospective research studies focused on pediatric spinal deformity.
Innovent expands global Phase 3 study of IBI363/TAK-928 to include non-squamous NSCLC
Lundbeck to relocate US headquarters to Greater Boston
FDA approves WELIREG and LENVIMA combination for previously treated advanced renal cell carcinoma
AstraZeneca's IMFINZI combination receives US Priority Review for muscle-invasive bladder cancer
Novotech to acquire Agilex Biolabs from Healius
ACROBiosystems launches CHO-Direct and ACRO AIx to accelerate AI-driven drug discovery
UChicago Medicine completes construction phase of new cancer facility
Viking Therapeutics plans offerings of common stock and convertible senior notes
Astellas doses first patient in Phase 3 lung cancer study
AstraZeneca's Trixeo Aerosphere approved in EU for asthma maintenance treatment
Ondine Biomedical deployssteriwave across five Southern Ontario hospitals
Ionis reports positive Phase 3 sefaxersen data in IgA nephropathy