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.
Source: GSM · USA (original Chinese edition)
Photo: 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.
