FDA approves Ellipsys Vascular Access System from Avenu Medical, Inc. to make an arteriovenous fistula for hemodialysis patients

The FDA has granted marketing authorization for the use of the Ellipsys Vascular Access System from Avenu Medical, Inc to make what's called an arteriovenous (AV) fistula for patients who need hemodialysis access. According to the National Institutes of Health, more than 661,000 Americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or artificial kidney, to filter a patient's blood outside of their body. Before patients can start dialysis, however, they need to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the mature vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically take several months to heal and for the vein to mature before being usable for hemodialysis. The devices granted marketing authorization is designed to create AV fistulas percutaneously (through the skin). A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The device then delivers energy to form a connection between an upper forearm artery and an adjacent vein.

For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multi-center study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3 percent) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.1 percent) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

The device is contraindicated, or should not be used, for creation of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications include blocking (occlusion) or collapse (stenosis) of the fistula, bruising and need for additional procedures.