Technology

Superior patient care and evidence-based outcomes

Surgeons perform approximately 350,000 to 480,000 discectomies per year in the United States. While those procedures are generally very successful, certain patients are at higher risk of recurrent lumbar disc herniation (rLDH) after surgery. An individual with a large defect in the annulus fibrosis (≥ 6mm wide), in particular, faces more than twice the risk of symptom recurrence, reoperation, and early readmission — all of which are associated with inferior clinical outcomes and substantial direct healthcare costs.

Two decades of research, development, rigorous testing, and robust clinical studies have placed the odds for a more durable outcome in your favor when performing discectomies on patients with large annular defects. The reason is Barricaid, a pioneering annular closure device (ACD) that has demonstrated significant benefits through more than a decade of clinical research and use. Barricaid enables you to perform a more disc-preserving discectomy while reducing the risk of reherniation and associated reoperations and early readmissions.

The need to avoid repeat surgery for large-defect patients

Repeat surgery after rLDH is more complex than primary discectomy. Altered anatomy from previous surgery, scarring, and increased risk of dural tears are a few of the issues that contribute to less successful results. Multiple large studies found that clinical outcomes for patients who undergo reoperation are worse than outcomes for patients who don’t require revision surgery.^6,7,8 Researchers such as Leven, O’Donnell, and Ahn found that rLDH patients who require revision surgery after primary discectomy:

• reported worse outcomes for pain and disability
• were less likely to return to work
• spent more days in the hospital than patients who did not require revision surgery.

Barricaid has proven to be a safe and effective means of significantly improving the outcomes of lumbar discectomies for treatment of symptomatic lumbar disc herniations (LDH) in primary discectomy patients with large defects. Given the level-I clinical evidence that Barricaid reduces symptomatic recurrent herniation by 52% and associated reoperations by 61% for this population, Barricaid represents a significant breakthrough for at-risk patients. It is one of the most rigorously proven spinal devices to demonstrate a clear patient benefit over an extended timeframe.

Connect with our Market Access team »

Barricaid patient population—disc worth preserving with large defect

Barricaid is indicated for skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation at a disc with at least 5mm of disc height. The implant comes in two sizes and is specifically designed to treat annular defects between 4 – 6mm tall and 6 – 10mm wide at a single level between L4 and S1. Patient history, physical examination, and imaging studies will help you determine the suitability of Barricaid for any given patient.

See here for complete list of indications and contraindications.

In treating this patient population, some surgeons have been aggressive in removing nucleus material in hopes of preventing reherniation. Unfortunately, more radical nucleus removal has been shown to result in greater disc height loss, significantly higher levels of back pain, and worse clinical outcomes than more limited nucleus removal.¹ We designed Barricaid so that you can close the annulus and preserve as much healthy tissue as possible.

Bone-anchored annular closure—how Barricaid works

Barricaid is the only FDA PMA-approved technology indicated for annular closure on the market. The implant is anchored to healthy bone with a titanium component that you secure to an adjacent vertebral body. Barricaid also includes a flexible polymer component designed to occlude your patient’s annular defect. As a result, Barricaid is designed to withstand 330 psi of pressure in the spinal disc. It also allows for normal anatomical movement following surgery.

The Barricaid system includes two annular closure implant widths, one with 8mm and a second with 10mm wide occlusion component — (a polyester fabric component designed to close the annulus), that are preloaded onto disposable delivery tools. The size of implant you use will depend on the width of the defect, which you will determine intraoperatively using the defect measurement tools provided with the Barricaid system. The implantation procedure is fluoroscopy guided to properly align and anchor Barricaid into an adjacent vertebral body. Implantation follows a primary discectomy procedure.

Clinical evidence—Barricaid reduces reoperations

Barricaid’s path to FDA approval for use in the United States involved the treatment of thousands of patients over a ten-year period, studies of seven distinct patient populations (including a level-I randomized study),  and 40+ peer-reviewed publications. Throughout these multi-year studies, Barricaid has consistently achieved excellent results and superior outcomes when compared to discectomy alone.

A 554-patient, level-I clinical study leading to FDA Pre-Market Approval published in The Spine Journal 18 (2018) 2278–2287² reported that Barricaid patients in this study steadily outperformed non-Barricaid patients in freedom from symptomatic reherniation at three-month, six-month, one-year, and two-year follow ups. A 2019 article published in World Neurosurgery³ indicates that patients who received the Barricaid ACD had more favorable clinical outcomes for symptomatic reherniation (50% lower rate) and reoperation (43% lower rate) at three-year follow ups. Those patients also reported better outcomes related to leg pain, back pain, and the Oswestry Disability Index (ODI). 

While Barricaid significantly reduces the risks of early readmission, reherniation, and repeat surgery, the risk is not reduced to zero. When reoperation is necessary, the level-I RCT has demonstrated no additional intraoperative or perioperative risks when compared to discectomy alone.

See here for complete risk-benefit information.

Patient access support system

Since Barricaid is a new and innovative treatment option, approved by the U.S. Food and Drug Administration for the uses described on this site, some insurance companies may not yet be familiar with the Barricaid device and data. That’s why our Barricaid team includes patient-access experts who will work with you and your patients to navigate the prior authorization process.

Contact us directly to get started.