Avenu Medical wins CE Mark for Ellipsys vascular access system

Vascular access system maker Avenu Medical said today it won CE Mark approval in the European Union for its Ellipsys vascular access image-guided catheter system designed to percutaneously create arteriovenous fistulas for hemodialysis access. The company also said it won investigational device exemption approval from the FDA for the device, claiming it is the 1st device to receive IDE clearance for the minimally invasive creation of arteriovenous fistulas. “This is a major milestone both for our company and for the patients and physicians within the end stage renal disease communities. In the United States and around the world, there is a shortage of dedicated vascular access surgeons who can create AV fistulas. Our Ellipsys System has the potential to increase the number of clinicians performing vascular access procedures which may improve patient care by reducing time from request for fistula to usable access for dialysis. This, in turn, reduces the morbidity associated with temporary catheter access. In short, it represents significant quality of life improvement opportunity for this patient community. At the end of the day, approvals such as the CE Mark are exciting because we know that Ellipsys – and the percutaneous AV fistula creation it enables – can transform vascular access for dialysis patients. The Ellipsys technique will provide substantially more patients with a working fistula, for both pre-dialysis patients and existing dialysis patients,” pr...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Regulatory/Compliance Vascular Avenu Medical Source Type: news