Saturday, June 22, 2024

Cervical Spine: Spineart Secures FDA Clearance for Anterior Cervical Cage

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Cervical spine advancements have taken a significant step forward as Spineart, a Switzerland-based medical device company, has received FDA clearance for its Scarlet AC-Ti anterior cervical cage. The device is designed with a porous titanium framework to encourage cell proliferation, utilizing Spineart’s Ti-LIFE technology, which closely mimics the trabecular bone structure. This innovative design aims to enhance patient outcomes by promoting bone growth and stability in cervical spinal fusion procedures.

The Scarlet AC-T system integrates an implant interbody device with a cervical plate, creating a comprehensive solution for cervical spinal fusion. This design is an extension of Spineart’s Scarlet system, initially developed for anterior lumbar use. The key differentiator for Spineart’s devices is the Ti-LIFE technology, an additive manufacturing process that provides a porous titanium framework. This framework has an average pore diameter of 0.9mm and a porosity between 70% and 75%, facilitating cell colonization and bone growth.

Cervical Spine Market Shift: Metal Interbody Devices Decline as PEEK Gains Popularity

The global metal interbody device market for spinal fusion was valued at $293 million in 2023 and is projected to decline to $233 million by 2033. This anticipated decrease is partly due to the growing popularity of non-metal interbody devices, such as those made from carbon fiber and polyetheretherketone (PEEK). The PEEK market is expected to grow significantly, from $2.7 billion in 2023 to $4.6 billion by 2033. Despite this shift, Spineart’s 3D-printed titanium interbody cages have demonstrated superior bone cell proliferation compared to PEEK cages in animal studies.

Spineart’s chief commercial officer, Alessia Erlingher, emphasized the importance of the FDA approval, stating, “This approval underscores our commitment to innovation, continuously evolving our most successful products, such as the Scarlet system.” The approval represents another milestone for Spineart, which recently raised $22 million (SFr20 million) in financing. This funding will support two investigational device exemption (IDE) studies for a cervical intervertebral disc replacement device, the opening of a new research and development center in the United States, and the completion of a new factory in Geneva by the end of 2024.

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Cervical Spine Surgery: Spineart’s Scarlet AC-Ti System Enhances Fusion and Stability

Interbody cages are critical components in spinal fusion surgeries, acting as space holders between vertebrae to decompress the spinal cord and nerve roots. These cages are hollow, allowing bone to grow through them, promoting fusion and stability. Spineart’s Scarlet AC-Ti system aims to improve the effectiveness of these surgeries by combining the benefits of an interbody device and a cervical plate, while the porous titanium structure enhances bone integration and healing.

Spineart’s FDA clearance for the Scarlet AC-Ti anterior cervical cage is a significant step forward in the field of spinal fusion surgery. The innovative design, leveraging Ti-LIFE technology, aims to improve patient outcomes by facilitating bone growth and stability. As the market for spinal fusion devices evolves, Spineart continues to innovate and expand its product offerings, supported by substantial funding and strategic development initiatives. This approval not only highlights the company’s commitment to advancing medical technology but also sets the stage for further advancements in spinal care.

Resource: Prnewswire, May 28, 2024

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