The FDA has cleared catheter-based vascular access systems for sale. Both devices enable physicians to create arteriovenous (AV) fistulas through the skin, thereby simplifying a vital preparatory step for hemodialysis patients.
Avenu Medical and TVA Medical secured the clearances for the Ellipsys Vascular Access System and everlinQ endoAVF System, respectively. The details of the devices and the data generated on them to date differ in some notable ways. But overall the products use similar technology to address the same medical need.
The need centers on how kidney failure patients are prepared for hemodialysis. To perform the blood-cleansing process, healthcare professionals need a way to route blood out of and into the body. This access can be enabled by an AV fistula, a surgically created connection between an artery and vein in the arm. Once healed, the fistula can receive the two needles that facilitate hemodialysis.
Successful AV fistulas outperform other hemodialysis access methods against multiple patient and financial outcomes. But it can take many months and multiple interventions to get the fistula ready for hemodialysis. A significant proportion of AV fistulas never mature to the point that they are ready for use in the procedure.
Avenu and TVA want to cut the time, money and patient burden involved in the creation of these access points. The company’s devices feature catheters that the physician guides along a blood vessel in the arm to the site of the planned AV fistula. Upon reaching the site, the devices release energy to connect an artery to a vein, creating a fistula.
The companies have generated some data to support their claims that their devices are a better option than the traditional surgical approach to AV fistula creation. In clinical trials, more than 85% of people treated with the devices had usable AV fistulas within three months.
Additional procedures such as balloon angioplasty were common, though. In the Ellipsys trial, 96% of patients required another procedure in the first 12 months. The figure for the everlinQ trial was 28%, but 97% of participants in that study required an additional procedure when the fistula was created.
With 510(k) clearance secured, attention will now turn to commercialization. Avenu and TVA, like all device makers, will need to secure payer coverage. The companies also face the challenge of getting healthcare systems to embrace a different approach to the creation of AV fistulas.