2020.09.12正式通過TFDA成為CTL Amedica的亞洲總代理

本公司與美國CTL Amedica 「THE IDEAL BIOMATERIAL FOR FUSIONS」
合作申請之Valeo II 腰椎椎間融合器, 衛部醫器輸字第 033665號; the Valeo C+CSC 頸椎椎間融合器, 衛部醫器輸字第 033666號; Valeo II 頸椎椎間融合器, 衛部醫器輸字第 033667號，經由衛生福利部許可取得證照. ，於中華民國109年9月10日經CTL Amedica發布這個好消息。
(以下是CTL Amedica敘述)

The Taiwan Food and Drug Administration has granted CTL Amedica Corporation a license for three silicon nitride spine products.

DALLAS (PRWEB) September 10, 2020

The Taiwan Food and Drug Administration (TFDA) has granted CTL Amedica Corporation a license for three silicon nitride spine products – the Valeo II Lumbar Interbody Fusion Device, number 033665; the Valeo C+CSC Cervical Interbody Fusion Device, number 033666; and the Valeo II Cervical Interbody Fusion Device, number 033667. The official license enables CTL Amedica to market these products in Taiwan, a crucial medical device market, particularly for spinal technology.

“We began laying the groundwork for entrance into this important, thriving market upon participating in the 14th Annual Meeting of the Taiwan Neurosurgical Society in 2019, and we are pleased to see these efforts coming to fruition,” says Daniel Chon, CTL Amedica Corporation president and CEO. “The Valeo product line features our proprietary silicon nitride spine technology – the ideal biomaterial for fusion.”

CTL Amedica is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response.

“We are very excited to put CTL Taiwan in motion and look forward to working with our Taiwan distributor partner, Watson Biomedical Technology of New Taipei City, to make this unparalleled technology readily available throughout the country and eventually in markets throughout Asia.”

The Valeo product line is projected to commercialize late 2020 in Taiwan.

CTL Amedica Corporation is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, CTL Amedica is the world’s exclusive provider of silicon nitride spine products. For more information, visit https://www.ctlamedica.com/.