A spine device that received FDA premarket approval 72 hours before the cessation of elective surgeries in the U.S. in March 2020 has been shown to reduce the chance of disc herniations in patients who have already herniated a disc, The News Times reported July 13.
The Barricaid implant, developed by Intrinsic Therapeutics, has a polyester flap to close the tear in the disc and a jagged anchor that inserts into the bone to hold it in place.
Between 350,000 and 480,000 discectomies are performed in the U.S. every year, according to Intrinsic Therapeutics, which said that its Barricaid device has been shown to reduce the chance of disc reherniation to about 10 percent to 11 percent.
The claims are backed up by five-year studies conducted in Europe, the company said.
The device has been used in about 250 patients in the U.S. — where it was granted premarket approval in March 2020 — and in about 8,000 surgeries in Europe, Australia and Asia, according to Intrinsic Therapeutics.
David Bomback, MD, of Danbury-based CT Neck and Back Specialists, performed the first procedure in the state in June. "I'm always cautious with new technology," he said. "I always try to stay one or two fads behind."
"Although I did adopt it early, I still waited to see 8,000 patients done internationally before I hopped on the bandwagon," Dr. Bomback said. "I just wanted to stay on the sidelines and make sure that there were not any long term device-related complications."
Intrinsic Therapeutics has virtually trained more than 100 surgeons and estimates that the device has been used in over 30 states, according to the report.