Barricaid Annular Closing Device

Barricaid Annular Closing Device

https://www.barricaid.com

The bulk of the information regarding the use of annular closure devices in the prevention of recurrent herniation following lumbar discectomy comes from a randomized clinical trial (RCT) to evaluate the use of Barricaid device (Barricaid, Intrinsic Therapeutics, Inc, Woburn, MA) 1).

Previously reported long-term outcomes (3 years) of this RCT have shown a significant decrease in symptomatic reherniation (14.8 vs 29.5%) and reoperation (11 vs 19.3%) rates when compared with the control group 2).


Barricaid is designed to close large defects in the annulus, so to prevent recurrent disc herniation, while allowing the surgeon to preserve more of the patient’s lumbar disc.

The Barricaid Anular Closure device consists of a woven polyester occlusion component intended to block an anular defect, while anchored to the adjacent vertebral body by a titanium bone anchor.

Reinforcing the annulus fibrosus with Barricaid during lumbar discectomy may slow the progression of facet joint degeneration 3).


The polymer mesh is placed on the inner surface of the disc annulus, using the disc pressure to help seal the defect against leakage of the nucleus pulposus. Once wound dissection and (partial, hemilaminectomy has been done, discectomy is followed. However, aggressive nucleus removal has been shown to result in significant back pain and worsened clinical outcomes. After discectomy, the annular defect size is measured and the appropriately sized device is chosen. The titanium anchor is inserted into the bone (parallel to the surface of the endplate) and the mesh forms a barrier that blocks the defect.

The device provides permanent fixation through the bone anchorage and remains inside the disc. During the procedure, fluoroscopic guidance is required to ensure the appropriate location of the device.

Annular closure device insertion allows more nucleus to be left inside of the annulus and restores intra-discal pressure. Because only partial volume is removed from the intervertebral disc, this procedure can preserve disc height and motion and reduce facet degeneration


Patients with primary lumbar disc herniation show Endplate changes (EPC) in the corresponding segments. There is a significant increase in lesion number and size within 12 months after discectomy. This increase is significantly more pronounced in the annular closure device (ACD) group. The presence and growth of EPC are not correlated with low-back pain or ODI 4).

Study registration: ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580 5)

Barricaid Annular Closing Device case series.

Barricaid Annular Closing Device case reports.

Kurzbuch AR, Fournier JY, Tuleasca C. The annular closure device – panacea of lumbar disc herniation: how closed is closed enough for the intervertebral disc space? Acta Neurochir (Wien). 2021 Feb 19. doi: 10.1007/s00701-021-04764-9. Epub ahead of print. PMID: 33606100.


1)

Thomé C, Klassen PD, Bouma GJ, Kuršumović A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Fröhlich S, Wolfs J, Assaker R, Van de Kelft E, Köhler HP, Jadik S, Eustacchio S, Hes R, Martens F, Annular Closure RCT Study Group (2018) Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J 18(12):2278–2287
2)

Kienzler JC, Klassen PD, Miller LE, Assaker R, Heidecke V, Fröhlich S, Thomé C, Annular Closure RCT Study Group (2019) Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir 161(7):1389–1396
3)

Trummer M, Eustacchio S, Barth M, Klassen PD, Stein S. Protecting facet joints post-lumbar discectomy: Barricaid annular closure device reduces risk of facet degeneration. Clin Neurol Neurosurg. 2013 Aug;115(8):1440-5. doi: 10.1016/j.clineuro.2013.01.007. Epub 2013 Mar 6. PubMed PMID: 23473658.
4)

Barth M, Weiß C, Bouma GJ, Bostelmann R, Kursumovic A, Fandino J, Thomé C. Endplate changes after lumbar discectomy with and without implantation of an annular closure device. Acta Neurochir (Wien). 2018 Apr;160(4):855-862. doi: 10.1007/s00701-017-3463-y. Epub 2018 Feb 2. PMID: 29396603.
5)

Strenge KB, DiPaola CP, Miller LE, Hill CP, Whitmore RG. Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol. Medicine (Baltimore). 2019 Aug;98(35):e16953. doi: 10.1097/MD.0000000000016953. PMID: 31464935; PMCID: PMC6736093.

Stealth Autoguide

Stealth Autoguide

Stereotaxy is routinely performed for brain biopsydeep brain stimulation, and placement of stereoelectroencephalography (SEEG) electrodes for epilepsy. The developed Stealth Autoguide (MedtronicMinneapolis, MN, USA) device does not require patients to don a stereotactic frame.

In a preclinical study, Brandman et al. sought to quantitatively compare the Stealth Autoguide robotic system to 2 devices commonly used in clinical practice: the Navigus biopsy system (Medtronic) and the Leksell stereotactic frame (Elekta Ltd., StockholmSweden).

In the first experimental setup, they compared target accuracy of the Stealth Autoguide to the Navigus system by using phantom heads filled with gelatin to simulate the brain tissue. In the second experimental setup, they inserted SEEG electrodes to targets within cadaveric heads in a simulated operating room environment.

Using a homogeneous gelatin-filled phantom 3D reconstruction of a human head, they found that using the Stealth Autoguide system while maintaining accuracy, was faster to use than the Navigus system. In the simulated operating room environment using nonliving human cadaveric heads, they found the accuracy of the Stealth Autoguide robotic device to be comparable to that of the Leksell stereotactic frame.

These results compare the use of the Stealth Autoguide robotic guidance system with commonly used stereotactic devices, and this is the first study to compare its use and accuracy with the Leksell frame. These findings provide mounting evidence that Stealth Autoguide will have potential clinical uses in various stereotactic neurosurgical procedure1).


1)

Brandman D, Hong M, Clarke DB. Preclinical Evaluation of the Stealth Autoguide Robotic Guidance Device for Stereotactic Cranial Surgery: A Human Cadaveric Study. Stereotact Funct Neurosurg. 2021 Feb 10:1-8. doi: 10.1159/000512508. Epub ahead of print. PMID: 33567429.

RONNA

RONNA

http://www.ronna-eu.fsb.hr/


Dlaka et al. present et al. a novel robotic neuronavigation system, RONNA G4, used for precise preoperative planning and frameless neuronavigation, developed by a research group from the University of Zagreb and neurosurgeons from the University Hospital Dubrava, Zagreb, Croatia. The aim of the study is to provide a comprehensive error measurement analysis of the system used for brain biopsy.

Frameless stereotactic robot-assisted biopsies were performed on thirty-two consecutive patients. Post-operative CT and MRI scans were assessed to precisely measure and calculate target point error (TPE) and entry point error (EPE).

The application accuracy of the RONNA system for TPE was 1.95 ± 1.11 mm, while for EPE was 1.42 ± 0.74 mm. The total diagnostic yield was 96.87%. Linear regression showed statistical significance between the TPE and EPE and the angle of the trajectory on the bone.

The RONNA G4 robotic system is a precise and highly accurate autonomous neurosurgical assistant for performing frameless brain biopsies 1).


Dlaka et al. in 2017 presented a case study of a frameless stereotactic biopsy guided by the RONNA G3 robotic neuronavigation system.

A 45-year-old patient with a history of vertigo, nausea, and vomiting was diagnosed with multiple periventricular lesions. Neurological status was unremarkable. A frameless robotic biopsy of a brain lesion was performed.

Three tissue samples were obtained. There were no intraoperative or postoperative complications. Histological analysis showed a B-cell lymphoma. After merging the preoperative CT scan with the postoperative MRI and CT scans, the measured error between the planned and the postoperatively measured entry point was 2.24 mm and the measured error between the planned and postoperatively measured target point was 2.33 mm.

The RONNA G3 robotic system was used to navigate a Sedan brain biopsy needle to take tissue samples and could be a safe and precise tool for brain biopsy 2).


1)

Dlaka D, Švaco M, Chudy D, Jerbić B, Šekoranja B, Šuligoj F, Vidaković J, Romić D, Raguž M. Frameless stereotactic brain biopsy: a prospective study on robot-assisted brain biopsies performed on 32 patients by using the RONNA G4 system. Int J Med Robot. 2021 Feb 16. doi: 10.1002/rcs.2245. Epub ahead of print. PMID: 33591608.
2)

Dlaka D, Švaco M, Chudy D, Jerbić B, Šekoranja B, Šuligoj F, Vidaković J, Almahariq F, Romić D. Brain biopsy performed with the RONNA G3 system: a case study on using a novel robotic navigation device for stereotactic neurosurgery. Int J Med Robot. 2017 Dec 12. doi: 10.1002/rcs.1884. [Epub ahead of print] PubMed PMID: 29232764.
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