Posted byOrthoEx Posted in,
Posted on Dec 14, 2017

By Joyce Frieden, News Editor, MedPage Today/December 13, 2017

GAITHERSBURG, Md. — An FDA advisory committee voted 5-8 Tuesday, with one abstention, against recommending approval of the Barricaid prosthesis for partial anulus replacement in patients with herniated discs.

“There was a high rate of breakage of the device, a high rate of migration, and [there was] the unknown nature of [some endplate] lesions,” said Eli Baron, MD, of the Cedars Sinai Spine Center in Los Angeles, a member of the FDA’s Orthopaedic and Rehabilitation Devices Panel. Many of the users of the device would be younger patients, “most in their 30s and 40s, and we don’t know what will happen down the line.” He voted that the risks of the Barricaid device, which is manufactured by Intrinsic Therapeutics, outweighed its benefits.

But committee member Ty Subhawong, MD, of the University of Miami, disagreed. “[The device is] reasonably safe, and I think the major concerns were centered around the endplate lesions and while there were some theoretical concerns about harbingers of device failure …. the number of lesions observed was sufficient to reassure me that there is nothing catastrophic about these devices,” said Subhawong, who voted in favor of recommending approval. He added, however, that a post-approval study would be a good idea.

The committee also voted 12-1 that the device was shown to be effective in the patients it was indicated for, but by a vote of 5-9, they did not agree that the device was shown to be safe.

The Barricaid implant is a polymeric mesh that sits in the posterior intervertebral disc space; it is connected to a metallic anchor that is attached to the vertebral body, the FDA explained in a briefing document issued prior to Tuesday’s meeting. The implant comes with a delivery tool and manual surgical instruments, which are used in a posterior/posterolateral approach.

The Barricaid Anular Closure Device is a permanent implant used after a limited lumbar discectomy performed for treatment of lumbar radiculopathy. The device is designed to mechanically block an opening in the anulus, thereby maintaining the relative position of nucleus within the disc space to prevent reherniation following limited discectomy in patients with large anular defects at an increased risk of reherniation.