The FDA has permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. Specifically, the FDA granted marketing authorization for the use of the Ellipsys vascular access system (Avenu Medical) and the everlinQ endoAVF system (TVA Medical, Inc.) to make what is 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 are designed to create AV fistulas percutaneously or 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 devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys system uses one catheter, and the everlinQ endoAVF system uses two.
For the Ellipsys system, the FDA reviewed data from a nonrandomized, multicenter study of 103 patients. The Ellipsys system was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3%) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.1%) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.
For the everlinQ endoAVF system, the FDA reviewed data from a nonrandomized, multicenter study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the U.S. The everlinQ endoAVF system was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients (86.7%) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.7%) required an additional procedure at the time the fistula was created, while 28.3% of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.
Both devices are contraindicated for creation of anastomoses in vessels that are less than 2 mm in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications include occlusion or stenosis of the fistula, bruising, and need for additional procedures.
The Ellipsys vascular access system and everlinQ endoAVF system were reviewed through the de novo premarket review pathway, a regulatory pathway for some low-to-moderate–risk devices of a new type. This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
Source: FDA; June 22, 2018.