AMI6005: Medtronic Avenu Ellipsys 6F Vascular Access System Catheter for AVF

Expired » Medtronic Vascular » Vascular Access

Medtronic Avenu Ellipsys 6F Vascular Access System Catheter

Provides a minimally invasive percutaneous AV fistula without an incision or suture.

The Ellipsys® Vascular Access 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 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

Product Code: AMI6005

• 6F, single catheter
• Ultrasound guided
• Venous access
• Immediate and permanent fused anastomosis
• Designed for all sites of service, including HOPD, ASC and OBL

Additional Details

• Company Name: Avenu Medical, Inc
• FDA Product Code: PQK
• FDA Product Code Name: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
• GMDN Term Code: 45630
• GMDN Term Name: Electrocautery system, line-powered
• GMDN Term Definition: An assembly of line-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.

Medtronic Cardiovascular Therapies offers a broad range of solutions for treating peripheral artery disease, aortic aneurysms, deep vein thrombosis, and other vascular conditions. Key technologies include the Endurant II and Endurant IIs stent graft systems for abdominal aortic aneurysms, the IN.PACT Admiral drug-coated balloon for femoropopliteal disease, and the Abre venous self-expanding stent system for iliofemoral venous outflow obstruction. With a commitment to advancing minimally invasive therapies, Medtronic’s vascular innovations help restore blood flow, reduce procedural risk, and improve quality of life for patients with complex vascular disease.

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