Avenu Medical, Inc.
Avenu Medical, now a part of Medtronic, is dedicated to creating a paradigm shift in vascular access for hemodialysis patients. Our focus is to pursue unmet clinical needs by developing a minimally invasive, cost effective and efficient approach to vascular access. Founded in 2010 and headquartered in Orange County, California, we have developed the Ellipsys Vascular Access System, an innovative, image-guided, single catheter system used to percutaneously create an arteriovenous (AV) fistula for hemodialysis access (EndoAVF). The Ellipsys System is approved by the Food and Drug Administration (FDA) for EndoAVF creation. Approval was received after completing a pivotal clinical trial in the United States with one year patient follow-up. The Ellipsys System has also received European CE Mark approval for the creation of an arteriovenous fistula in patients with chronic kidney disease requiring hemodialysis.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 2010
About Us
Ellipsys.
A minimally invasive approach to AV fistula creation.
The Ellipsys Vascular Access System has received FDA approval in the U.S. and European CE Mark approval for the creation of an arteriovenous fistula in patients with chronic kidney disease requiring hemodialysis.
Three strong reasons to rely on Ellipsys:
- Its reputation as the only system of its kind with published U.S. data, cleared for use in HOPD, ASC and OBL settings.
- Its patented tissue fusion technology, enabling immediate, minimally invasive creation of permanently fused anastomosis.
- Its track record of achievement in over 2000 procedures, with long-term functional patency. And that’s reason enough to learn more about Ellipsys today.
- 2,500,000 2.5 million hemodialysis patients worldwide
- 8 % Patient population growing at 8% per year
- 3,400,000 3.4 million hemodialysis patients worldwide by 2020
AV fistula creation methods have not changed in 50 years. Ellipsys is changing that.
- Provides a minimally invasive percutaneous AV fistula without an implant
- Is a minimally invasive procedure
- Utilizes upper arm AVF for hemodialysis
- Is ultrasound image guided
- Enables single catheter venous access
- Enables intravascular sealing of the vein and artery
- Leaves the vasculature at the AVF site undisturbed
- Requires only regional or local anesthesia
- Avoids technique-dependent vessel suturing
Patient Market
Hemodialysis patient population is growing at 8% per year.
Due to the increasing prevalence of diabetes, hypertension and obesity, the number of patients treated for ESRD is growing at a rate that far exceeds the growth rate of the general population. Hypertension and diabetes alone account for 70% of all newly diagnosed patients with ESRD1. The aging population and higher life expectancy of patients on dialysis also contributes to the numbers of patients being treated.
Worldwide, 2.5 million patients are treated annually with hemodialysis that requires the creation or revision of a vascular access. And the dialysis population around the world is expected to exceed 3.4 million by 2020. The Ellipsys® Vascular Access System has the potential to save billions annually in healthcare costs because it does not involve the traditional method requiring surgery.