X9透析穿刺系统获美国食品药品监管局 FDA 突破性医疗器械认定：第二项临床研究10名患者无器械相关不良事件
总部位于 Connecticut 州 Wallingford 的医疗科技公司 X9 于10月26日宣布，美国食品药品监管局（FDA）已授予其在研的 X9 超声系统（带动力辅助穿刺针插入功能）突破性医疗器械认定；该系统拟用于以成像与引导帮助医护人员确认合格的血管通路部位、辅助引导穿刺针插入，为经动静脉内瘘接受血液透析的患者完成穿刺。公司同日宣布，其第二项临床研究 ACCESS-2 已完成。
ACCESS-2 是一项前瞻性、单中心研究，共纳入10名经动静脉内瘘接受血液透析的患者，每名患者接受多次使用该在研器械辅助穿刺的透析治疗。公司称，研究中穿刺针成功置入并顺利开始透析，达到研究的主要安全目标，未报告严重器械相关不良事件，也未报告其他器械相关不良事件。
X9 首席执行官 Eb Bright 表示，可靠的血管通路对血液透析治疗至关重要，而穿刺置针仍是一道要求很高的操作；突破性认定与第二项研究结果是该系统开发进程中的重要进展，公司将继续推进临床开发。投资方 DaVita 的首席战略官 Steve Phillips 表示，DaVita 在日常诊疗中深知这类常规环节也会给患者带来不适，X9 的技术有望改变这一局面。
FDA 突破性医疗器械计划是一项自愿计划，面向有望更有效治疗或诊断危及生命或不可逆衰弱性疾病的器械，目的是加快这类器械的开发、评估与审查进程，让患者与医护人员更及时地用上新器械。X9 特别说明，突破性认定不等于该系统已获 FDA 批准或上市许可，也不保证今后一定取得上市授权，该系统目前仍属在研器械。
X9 是一家未上市医疗科技公司，由 ExploraMed 孵化器孵化成立，专注以成像、智能引导与器械辅助方式解决血管通路这一长期难题，应用场景包括透析及其他关键治疗。
X9 Dialysis Cannulation System Wins FDA Breakthrough Device Designation: Second Clinical Study in 10 Patients Reports No Device-Related Adverse Events
X9, Inc., a medical technology company based in Wallingford, Connecticut, announced on October 26 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its investigational X9 Ultrasound System with Power-Assisted Needle Insertion. The system is proposed to provide healthcare professionals with imaging and guidance to identify validated vascular access sites and assist with guided needle insertion for hemodialysis cannulation of vascular accesses. The company also announced completion of ACCESS-2, its second clinical study of the system.
ACCESS-2 was a prospective, single-center study in patients undergoing hemodialysis through an arteriovenous fistula. Ten patients were enrolled and underwent multiple dialysis sessions using investigational-device-assisted cannulation. The company said the study demonstrated successful needle placement with the X9 System and subsequent initiation of dialysis, met its primary safety objective, and reported no serious device-related adverse events and no other device-related adverse events.
Reliable vascular access is essential to hemodialysis treatment, yet needle insertion remains a demanding procedure, X9 chief executive Eb Bright said, calling the designation and the second study's results important progress as the company advances the system through continued clinical development. Steve Phillips, chief strategy officer at DaVita, an investor in X9, said the technology has the potential to change a routine but uncomfortable part of the healthcare experience, not only in kidney care but across healthcare.
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, intended to give patients and providers more timely access by expediting development, assessment and review. X9 noted that Breakthrough Device Designation does not constitute FDA clearance or approval of the system and does not guarantee future marketing authorization; the system remains investigational.
X9 is a privately held medical technology company launched from the ExploraMed incubator. It develops imaging, intelligent guidance and device-assisted approaches to longstanding vascular access challenges in dialysis and other critical therapies.
来源：GSM·美国（原文链接）
图片来源：图：血液透析机与治疗椅（资料图，非涉事器械）。照片：Vitaliy Pospelov，CC BY-SA，经 Wikimedia Commons。 / Photo: A hemodialysis machine and treatment chair (file photo; not the device in this story). Photo by Vitaliy Pospelov, CC BY-SA, via Wikimedia Commons.
