Zimmer Biomet wins first FDA approval for the Tether for treating scoliosis in pediatrics.
M2 PHARMA-August 19, 2019-Zimmer Biomet wins first FDA approval for the Tether for treating scoliosis in pediatrics
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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.
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|Date:||Aug 19, 2019|
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