The Intristic Therapeutics product was advised against by the FDA's Advisory Committee by a vote of 5-8, with 1 abstention.
In a meeting of the US Food and Drug Administration’s (FDA) advisory committee, the group chose to not recommend Intrinsic Therapeutics’ Barricad device, designed to reduce the risk of re-herniation after spinal surgery.
Ahead of the meeting today, the committee showed little interest in the clinical data submitted for the device, stating in pre-released documents that it viewed inconsistencies between the planned study population and the enrolled study population, which was filled in October 2014.
"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," Eli Baron, MD, of the Cedars Sinai Spine Center in Los Angeles, a member of the FDA's Orthopaedic and Rehabilitation Devices Panel, said in a statement. "most in their 30s and 40s, and we don't know what will happen down the line."
Additionally, the data gave the committee concerns, as 40% of the control group experienced end-plate lesions (EPLs) compared to 88% of the patients given the Barricad device. The committee also reported that “the control patients with EPLs have lesions that are smaller, appear to reach stability sooner, and present features more in line with Schmorl’s nodes,” according to FDA documents.
The committee revealed that the patients with the Barricad device had EPLs that were larger, progressed in size faster, had radiographically distinct features, and showed signs of mesh subsidence.
Intrinsic Therapeutics’ clinical trial consisted of 554 patients randomized 1:1 to a control group (n = 278) five discectomy alone, and a Barricad group (n = 276). Patients with the Barricad device were expected to demonstrate statistical superiority for the study’s endpoints: re-herniation-free recovery and a composite of patient outcomes (improvement in leg pain, Oswestry Disability Index, maintenance of disc height, and lack of reoperation).
The trial did show that the reoperation risk after 90 days for those with the device was 1.9% compared to 5.4% without (P = 0.3), and that the risk of both all-cause (9.7% vs 16.3%; P = .056) and procedure/device-related (4.5% vs 10.2%; P = .02) serious adverse events was lower with the device than without.
At the 24-month mark, about 50% of Barricaid patients had no re-herniation compared with 30.1% of the control group. The composite endpoint was achieved by 27.8% of Barricaid patients compared with 18.1% of control patients.
The device is supposed to close larger defects in the anulus in order to allow for orthopedic surgeons to minimize how much of the disc is actually removed. The Barricad consists of a piece of woven polyester fabric, intended to block the defects, and a titanium bone anchor. Patients with defects sized 4 to 6 mm in height and 6 to 12 mm in width would be eligible to use the device.
Originally, Intrinsic Therapeutics applied for an investigational device exemption (IDE) to undergo a clinical trial in the United States, but it was shot down becuase of safety concerns, as noted by the FDA.