Arteriovenous fistula creation
<p>The Ellipsys™ system is a single-catheter, nonsurgical option for physicians to create an arteriovenous (AV) fistula.</p>
Only the Ellipsys™ vascular access system uses a single point of venous access,1 offering the simplest, most minimally invasive option for arteriovenous fistula (AVF) creation.†,1,2 It provides an immediate, suture-free, permanently fused anastomosis1 that is clinically proven to improve longevity3-5 and reduce the risk of complications.3,5
The Ellipsys™ system enables a reproducible, minimally invasive procedure that requires no implant or suture, and allows patients to leave with just a single needle stick.1
The Ellipsys™ system is the only one of its kind with five-year U.S. clinical trial data1,3 demonstrating three critical metrics:
88% maturation rate at 90 days1
91.8% functional patency at five years3
82% cumulative patency at five years3
These clinical trial maturation and patency rates have also been demonstrated in registry trial data from more than 500 real-world patients in France, Germany, and the United States.5–7
Risks may include: total/partial occlusion or stenosis of the anastomosis, failure to achieve fistula maturation, Steal Syndrome, hematoma, infection, and need for vessel superficialization or other maturation assistance procedures.
Watch vascular surgeon Dr. Alexandros Mallios create an AV fistula using the Ellipsys™ vascular access system. (06:34)
Watch a typical Ellipsys™ vascular access system procedure as interventional nephrologist Dr. Rashid Sharaf walks through a case. (18:14)
| Item number | Description | Recommended introducer sheath (Fr) | Guidewire compatibility (in) | Vessel size (mm) |
|---|---|---|---|---|
| AMI6005 | Ellipsys™ catheter‡ | 6§ | 0.014 | 2.0 + |
| Item number | Description | Units per pack |
|---|---|---|
| AMI1001 | Ellipsys™ power controller (reusable) | 1 |
| K21-00022 | EndoAVF™ access kit hydrophilic sheath◊ | 5 |
† Compared to surgical arteriovenous fistulas.
‡ Requires AMI-1001 Ellipsys™ power controller (110-240 V, 50/60 Hz, reusable).
§ Maximum sheath length 10 cm. Prior to using a specific sheath, ask your sales or clinical representative if the sheath is compatible with the Ellipsys catheter. Sheaths that are too long may cover the working portion at the device tip.
◊ Includes 21 ga x 7 cm echo-tip micropuncture needle, 0.018” guidewire, and 6 Fr x 10 cm thin-walled radial artery sheath.
¶ The Ellipsys system and drug-coated balloons have not been used together in a clinical study.
