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,” prez Mark Ritchart said in prepared remarks.
Avenu Medical said it recently completed enrollment of its pivotal phase III IDE clinical trial designed to explore the safety and efficacy of its Ellipsys system.
“The procedure is simple and elegant. All the patients’ care from fistula creation through maturation is delivered in the office-based vascular center. Using the Ellipsys Vascular Access System is very similar to common procedures such as obtaining venous and arterial access with ultrasound. This new, minimally invasive procedure requires similar skills. Most physicians involved in vascular access have these skills and will learn to use the Ellipsys System quickly,” Dr. Jeffrey Hul of Richmond, Va.’s Richmond Vascular Center said in a prepared statement.
Last December, Avenu Medical raised $6 million in a round of debt financing, according to an SEC filing. Funds came from 46 anonymous investors, according to an SEC filing. No details on how the funds will be spent or who joined the round of funding have been disclosed by the company.
Avenu Medical founder Dr. Jeffrey Hull came up with the idea for the device after brainstorming with a friend about medical devices that haven’t changed in over 30 years, he told Endovascular Today in an interview last June.
