US-based medical device company Avenu Medical has secured the CE Mark approval to market its Ellipsys Vascular Access System to address the needs of vascular access for hemodialysis.
Avenu's Ellipsys System is expected to act as the modern alternative for the conventional AV fistula to address the requirement of dialysis patients for a continuous, effective and reproducible vascular access.
Often the patients have to wait for long to get a surgical AV fistula functional which results to the patients' extended exposure to central venous catheters increasing the risk of infection and mortality.
Avenu Medical president Mark Ritchart said: "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."
The single catheter image-guided system offers a minimally invasive procedure providing a percutaneous arteriovenous fistula (AVF) without an implant using the upper arm AVF for hemodialysis.
It is an outpatient procedure which requires regional or local anesthesia without depending on technique-oriented vessel suturing.
The Ellipsys System enables the intravascular sealing of the vein and artery through a single catheter venous access while leaving the vasculature at the AVF site unperturbed.
Avenue is enrolling patients for its US Food and Drug Administration (FDA) approved pivotal phase III IDE clinical trial of the Ellipsys System for the percutaneous creation of AV fistulas.