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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA