FDA clears catheter-based hemodialysis vascular access systems

FDA
Avenu and TVA want to cut the time, money and patient burden involved in the creation of AV fistulas. (FDA)

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.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

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. 

Suggested Articles

Philips is cementing its commitment to becoming a healthcare technology provider, with plans to split off or sell its consumer appliances division.

A new digital health startup is exiting stealth mode with its advanced, long-lasting patient monitoring device—and touting a quick FDA clearance.

The FDA granted an expanded indication to GT Medical’s GammaTile cancer therapy, broadening its use to newly diagnosed brain cancer patients.