FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical

The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical.

The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; TVA Medical makes the EverlinQ EndoAVF system.

“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” Dr. Bram Zuckerman, director of the cardiovascular devices division of the FDA’s Center for Devices & Radiological Health, said in prepared remarks.

The FDA said it granted clearance to Avenu’s device based on a 103-patient, non-randomized study in which 89.3% of patients met the criteria for a usable AV fistula within three months. Some 96.1% required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

TVA Medical’s clearance was based on another non-randomized study of 60 patients, plus data from three other studies and clinical use of the device outside the U.S., the agency said. Fifty-two patients, or 86.7%, met the three-month usable fistula benchmark, with 96.7% requiring an addition procedure when the fistula was created and 29.3% needing an additional procedure in the first year.

Neither device should be used to create anastomoses in blood vessels less than 2mm in diameter or too far apart. Complications for both include fistula occlusion or stenosis, bruising and the need for additional procedures, the FDA said.

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