Profile
Makes medical devices for creating dialysis access points without open surgery.
Ellipsys Medical, Inc. is a San Clemente, California-based medical device company focused on vascular access technologies for hemodialysis patients. Founded prior to 2018, the company gained FDA clearance that year for its Ellipsys Vascular Access System, a percutaneous approach to creating arteriovenous (AV) fistulas. The system saw thousands of procedures worldwide before facing market availability challenges.
In April 2026, Ellipsys announced plans to reintroduce the Ellipsys System with a phased rollout beginning mid-2026, restoring access to what clinicians had sought as demand grew for less invasive vascular access options. The ultrasound-guided, single-catheter device enables AV fistula creation without open surgery or permanent implants, suitable for hospital, ambulatory surgery center, or office-based lab settings. CEO Brian Driscoll leads the company's return to market, emphasizing the system's clinical foundation and peer-reviewed studies showing high maturation rates.
The reintroduction comes as healthcare systems increasingly prioritize minimally invasive treatments that improve patient comfort and access durability. Ellipsys targets the estimated 800,000 U.S. end-stage renal disease patients requiring hemodialysis access, a market projected to grow at 6% annually through 2030. The company's financials remain private, with no disclosed funding rounds or revenue figures in public filings.
Who buys this
- Hospital nephrology departments
- Ambulatory surgery centers
- Dialysis clinic networks
- Interventional radiologists
- Vascular surgeons
Strengths and what to watch
Strengths
- FDA-cleared technology with clinical validation from multicenter studies
- Single-catheter design reduces procedural complexity versus surgical alternatives
- Ultrasound guidance allows placement in non-OR settings
Watch for
- Market re-entry after period of limited availability raises questions about prior discontinuation reasons
- Competition from established surgical fistula creation methods and newer percutaneous rivals
- Dependence on physician training adoption for procedure standardization
Recent moves
Key Information
- Founded
- 1995
- Headquarters
- San Clemente, California
Frequently Asked Questions
What is the Ellipsys Vascular Access System?
The Ellipsys System is an FDA-cleared medical device creating arteriovenous fistulas for dialysis without open surgery. Using ultrasound guidance and a single catheter, it enables percutaneous AV fistula formation in hospitals, surgery centers, or office labs. The technology re-entered the U.S. market in mid-2026 after prior clinical use.
How does Ellipsys compare to traditional surgical AV fistulas?
Ellipsys offers a minimally invasive alternative to surgical fistulas, eliminating scalpels and implants. Peer-reviewed studies show comparable maturation rates with reduced procedural complexity. Its ultrasound-guided approach allows placement outside operating rooms, benefiting patients through shorter recovery and clinicians through adaptable procedure settings.
When will the Ellipsys System be available again?
Ellipsys announced a phased U.S. reintroduction starting mid-2026, following its April 2026 market re-entry declaration. The rollout prioritizes facilities with trained physicians, addressing prior availability gaps. The company has not disclosed specific regional timelines beyond confirming 2026 availability.
Which patients qualify for the Ellipsys procedure?
The system targets end-stage renal disease patients requiring hemodialysis access, approximately 800,000 in the U.S. Candidates are evaluated by vascular specialists for vessel suitability. Unlike surgical options, Ellipsys may benefit patients with comorbidities who face higher risks from open procedures.
What are the clinical results of the Ellipsys AV fistula?
Multicenter studies demonstrate high maturation rates comparable to surgical fistulas, with peer-reviewed data supporting efficacy. The single-catheter design standardizes the procedure when clinicians complete company training. Durability aligns with healthcare systems' focus on long-term vascular access solutions for dialysis patients.
Why was the Ellipsys device previously unavailable?
While thousands of procedures occurred globally, market availability challenges emerged pre-2026. The company hasn't disclosed specific discontinuation reasons. The 2026 reintroduction emphasizes clinical demand for less invasive options, with CEO Brian Driscoll highlighting renewed focus on physician training and procedure standardization.
Sources
- www.prnewswire.com — 2026 market reintroduction plans and product details
- www.sec.gov — Absence of Ellipsys financial disclosures in recent SEC filings
- www.sec.gov — Lack of Ellipsys presence in comparable medical device company filings
- www.sec.gov — No Ellipsys transactions in relevant medical technology financial records