Image: The everlinQ endoAVF system catheters (Photo courtesy of TVA Medical).
New technology uses magnetic catheters and radiofrequency (RF) energy to create an arteriovenous fistula (AVF) for hemodialysis access.
The TVA Medical (Austin, TX, USA) everlinQ endoAVF System is based on two flexible 6Fr magnetic catheters and RF energy generator. In order to form a consistent, hemodynamic AVF, the flexible magnetic catheters are first inserted into an artery and a vein in the arm. When they are in close proximity, the magnets in each catheter attract to each other, pulling the vessels together. After confirming alignment, a small burst of RF energy into the venous catheter opens an anastomosis between the artery and vein, creating the AVF. The catheters are then removed and a brachial vein is coil-embolized, enabling future dialysis.
“Thanks to extensive collaboration with the FDA, clinical study investigators and clinical advisors, we are thrilled to now partner with the U.S. vascular surgery and nephrology communities to offer an innovative endovascular fistula creation approach,” said Adam Berman, president and CEO of TVA Medical. “Training will begin immediately at select U.S. vascular surgery centers, and a U.S. post-market study is scheduled to initiate before the end of the year.”
“Hundreds of thousands of Americans require vascular access for lifesaving dialysis, but until now this access has required open surgery that is accompanied by high failure rates and low patient satisfaction,” said vascular surgeon Paul Kreienberg, MD, of Albany Medical Center Hospital (NY, USA). “The everlinQ endoAVF System is transforming vascular access using a minimally invasive approach, and I anticipate a high level of interest from both patients and physicians for this compelling endovascular solution.”
An AVF is still the most recommended access for kidney disease patients who must undergo dialysis, created by connecting a patient's vein and artery to form a long-lasting site through which blood can be removed and returned. Alternatively, in those unsuitable for an AVF, an arteriovenous graft--a plastic conduit between an artery and a vein--may be used. Many patients, however, prefer a catheter, for reasons that include inadequate preparation for dialysis, avoidance of surgery, or fear of needles (since the connection to the dialysis machine via a catheter does not require needles).