ZAP Surgical Systems, Inc., a leading innovator in the field of surgical robotics, today announced that the company received National Medical Products Administration (NMPA) approval in China for its ZAP-X® Gyroscopic Radiosurgery® platform.
ZAP-X was previously granted NMPA’s Chinese Medical Device Evaluation (CMDE) Green Pathway, an accelerated path for the examination and approval of innovative medical devices. As part of the priority review, a pre-approval clinical study was completed at PLA General Hospital 301 (PLAGH 301) in Beijing, China, which confirmed the overall patient safety and treatment efficacy of ZAP-X. PLAGH 301 is the largest hospital in China, with more than 20,000 outpatient treatments per day.
“Following an intensive, multi-year effort, we’re incredibly excited that the ZAP-X has finally received its regulatory approval in China,” said Dr. John R. Adler, Stanford Professor of Neurosurgery and Founder & Chief Executive Officer of ZAP Surgical Systems. “In time, China will become ZAP’s largest single market, which will benefit millions of Chinese brain cancer patients.”
With its ground-breaking design, the ZAP-X system uses unique gyroscopic mobility to direct radiosurgical beams from hundreds of unique angles to precisely concentrate radiation on the tumor target. This pioneering approach supports the clinical objective of protecting healthy brain tissue and preserving patient cognitive function.
The vault-free, cobalt-free ZAP-X is also renowned for eliminating the expense of building costly shielded radiation treatment rooms, and removing the need to maintain, secure and regularly replace live radioactive isotopes for radiation beam production.
ZAP Surgical获得中国国家药品监督管理局批准
继创新医疗器械特别审批后迎来的重大里程碑，将ZAP-X世界级的脑部肿瘤治疗技术带给中国的患者
外科机器人领域的领先创新企业ZAP Surgical Systems, Inc.今天宣布，该公司的头颈部X射线立体定向放射外科治疗系统ZAP-X® Radiosurgery System在中国获得了国家药品监督管理局(NMPA)的创新产品注册批准。
ZAP-X之前已获得中国国家药品监督管理局创新医疗器械特别审批。该系统在中国北京的中国人民解放军总医院（301医院）完成注册批准所需临床试验，确认了ZAP-X的患者的总体安全性和临床疗效。301医院是中国最大的医院之一，每天的门诊接诊量超过2万例。
ZAP Surgical Systems创始人兼首席执行官、斯坦福大学神经外科教授John R. Adler博士表示：“经过多年的艰苦努力，我们对ZAP-X终于在中国获得注册批准感到无比振奋。假以时日，中国将成为ZAP最大的单一市场，这将惠及数百万中国的脑部肿瘤患者。”
凭借其开创性的设计，ZAP-X系统使用独特的螺旋式移动技术，从数百个独特角度引导射束，精确地将射线集中在肿瘤目标。这种开创性的方法可支持保护健康的大脑组织和更好的保留患者认知功能的临床目标。
ZAP-X有自屏蔽技术、不使用钴60源，其广为人知的优势包括免除了建造昂贵的射线屏蔽治疗室的费用，以及无需放射源的维护、保障并定期更换。
ZAP Surgical獲得中國國家藥品監督管理局批准
繼創新醫療器械特別審批後迎來的重大里程碑，將ZAP-X世界級的腦部腫瘤治療技術帶給中國的患者
外科機器人領域的領先創新企業ZAP Surgical Systems, Inc.今天宣布，該公司的頭頸部X射線立體定向放射外科治療系統ZAP-X® Radiosurgery System平台在中國獲得了國家藥品監督管理局(NMPA)的創新產品註冊批准。
ZAP-X之前已獲得中國國家藥品監督管理局創新醫療器械特別審批。該系統在中國北京的中國人民解放軍總醫院（301醫院）完成註冊批准所需臨床試驗，確認了ZAP-X治療患者的總體安全性和臨床療效。301醫院是中國最大的醫院之一，每天的門診接診量超過2萬例。
ZAP Surgical Systems創始人兼首席執行官、斯坦福大學神經外科教授John R. Adler博士表示：「經過多年的艱苦努力，我們對ZAP-X終於在中國獲得監管部門的註冊批准感到無比振奮。假以時日，中國將成為ZAP最大的單一市場，這將惠及數百萬的中國腦部腫瘤患者。
憑藉其開創性的設計，ZAP-X系統使用獨特的螺旋式移動技術，從數百個獨特的角度引導射束，精確地將射線集中在腫瘤目標。這種開創性的方法可達到保護健康的大腦組織和更好的保留患者認知功能的臨床目標。
ZAP-X有自屏蔽技術、不使用鈷60源，其廣為人知的優勢包括免除了建造昂貴的射線屏蔽治療室的費用，以及無需放射源的維護和定期更換。
About ZAP Surgical Systems, Inc.
ZAP Surgical Systems, Inc. designs and manufactures the ZAP-X® Gyroscopic Radiosurgery® platform. ZAP was founded in 2014 by Dr. John R. Adler. In addition to being CEO of ZAP, Dr. Adler is Emeritus Dorothy & TK Chan Professor of Neurosurgery and Radiation Oncology at Stanford University. Dr. Adler is also renowned as the inventor of the CyberKnife® system and founder of Accuray, Inc. The ZAP-X platform incorporates a unique vault-free design that typically eliminates the need for costly shielded treatment rooms. ZAP-X also utilizes a modern linear accelerator to eliminate legacy use of Cobalt-60. Learn more at ZAP Surgical and follow us on LinkedIn and Twitter.
Contact: Mark Arnold, ZAP Surgical Systems, Inc.
Senior Vice President, Marketing
+1 650 492 7797, ext. 101
Email: info@zapsurgical.com