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.
TVA Medical said that its EverlinQ EndoAVF system uses magnetic catheters and radiofrequency energy to create an arteriovenous fistula for hemodialysis access without open surgery.
“FDA marketing authorization of the EverlinQ EndoAVF System is a monumental milestone for dialysis patients who now have an alternative AVF option. 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. 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,” prez & CEO Adam Berman said in a press release.
TVA Medical said it is beginning training at select US vascular surgery centers following approval, and added that its EverlinQ EndoAVF system won CE Mark approval in the European Union in 2014 and Health Canada approval in 2016.
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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.