The Ellipsys™ system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
The Ellipsys™ system is contraindicated for use in patients with target vessels that are < 2 mm in diameter. The Ellipsys™ System is contraindicated for use in patients who have a distance between the target artery and vein > 1.5 mm.
Potential complications that may be associated with creation and maintenance of an arteriovenous fistula include, but may not be limited to, the following:
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.
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The Ellipsys system and drug-coated balloons have not been used together in a clinical study.