Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis.
The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF.
“Using the Ellipsys vascular access system is very similar to common procedures such as obtaining venous and arterial access with ultrasound. Most physicians involved in vascular access have the endovascular skills required and will learn to use the Ellipsys System quickly,” Dr. Jeffrey Hull of Virginia’s Richmond Vascular Center said in prepared remarks.
The procedure is minimally invasive, does not cause scarring and does not require sutures, Avenu Medical said. Clearance from the FDA came based on data from a non-randomizes US multi-center study of 103 patients, the company added.
“This approval marks a seismic shift for the patients and physicians within the ESRD community. We can now offer a faster, more efficient and less-invasive option for patients requiring vascular access here in the US and worldwide. For too long there has been a shortage of dedicated vascular surgeons who can create AV fistulas leading to delays in performing the surgery and requiring expensive, temporary catheter access. Our Ellipsys system has the potential to significantly increase the number of clinicians performing vascular access procedures, thereby reducing these delays. This, in turn, will result in reduced morbidity and the cost associated with temporary catheter access. In short, it represents a quality of life improvement opportunity for this patient community,” prez Mark Ritchart said in a prepared statement.