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Disposable Laser Optical Fiber Kit Approved for Marketing

CCFDIE| Updated: 2023-04-04

Recently, the innovative product Disposable Laser Optical Fiber Kit of Sinovation (Beijing) Medical Technology Co., Ltd. is approved by China NMPA.

The core technologies such as materials, structure, and manufacturing process of this product have national invention patents. Under long-term working conditions, the optical fiber undergoes almost no deformation when heated, and therefore the intensity of laser scattering along the axis can relatively maintain consistency. This not only increases the treatment range, but also reduces the laser power density, thus effectively improving the safety of use.

This product, together with magnetic resonance monitoring semiconductor laser treatment equipment, achieves the minimally invasive treatment of intracranial lesions in neurosurgery, and is used for laser treatment of local lesions(with a clear epileptogenic area or a clear epileptic pathway) for patients with drug non-responsive epilepsy. Due to shorter treatment time, smaller damage to healthy brain tissues and less postoperative complications, patients will recover quickly, and the treatment difficulty of intracranial lesions in neurosurgery is reduced.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.