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Original research
Active drug-coated flow diverter in a preclinical model of intracranial stenting
  1. Robert M King1,
  2. Ahmet Peker2,
  3. Mark Epshtein1,
  4. Jennifer M Arends3,
  5. Alice B Brochu4,
  6. Christopher M Raskett1,
  7. Kimiko J Slazas1,
  8. Ajit S Puri1,
  9. Adam S Arthur5,6,
  10. David Fiorella7,
  11. Matthew J Gounis1,
  12. Vania Anagnostakou1
  1. 1 New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
  2. 2 Radiology, Koç University Hospital, Istanbul, Turkey
  3. 3 Preclinical, Stryker Neurovascular, Fremont, California, USA
  4. 4 Research and Development, Stryker Neurovascular, Fremont, California, USA
  5. 5 Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA
  6. 6 Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA
  7. 7 Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA
  1. Correspondence to Professor Matthew J Gounis, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, MA 01655, USA; matthew.gounis{at}


Background Flow diverters carry the risk of thromboembolic complications (TEC). We tested a coating with covalently bound heparin that activates antithrombin to address TEC by locally downregulating the coagulation cascade. We hypothesized that the neuroimaging evidence of TEC would be reduced by the coating.

Methods 16 dogs were implanted with overlapping flow diverters in the basilar artery, separated into two groups: heparin-coated (n=9) and uncoated (n=7). Following implantation, high-frequency optical coherence tomography (HF-OCT) was acquired to quantify acute thrombus (AT) formation on the flow diverters. MRI was performed postoperatively and repeated at 1, 2, 3, 4, and 8 weeks, consisting of T1-weighted imaging, time-0f-flight (ToF), diffusion weighted imaging (DWI), susceptibility weighted imaging (SWI), and fluid attenuated inversion recovery (FLAIR) sequences. Neurological examinations were performed throughout the 8-week duration of the study.

Results The mean AT volume on coated devices was lower than uncoated (0.014 vs 0.018 mm3); however, this was not significant (P=0.3). The mean number of foci of magnetic susceptibility artifacts (MSAs) on SWI was significantly different between the uncoated and coated groups at the 1-week follow-up (P<0.02), and remained statistically different throughout the duration of the study. The AT volume showed a direct linear correlation with the MSA count and 80% of the variance in the MSA could be explained by the AT volume (P<0.001). Pathological analysis showed evidence of ischemic injury at locations of MSA.

Conclusions Heparin-coated flow diverters significantly reduced the number of new MSAs after 1 week follow-up, showing the potential to reduce TEC.

  • flow diverter
  • aneurysm
  • bioactive
  • device
  • MRI

Data availability statement

Data are available upon reasonable request. Data are available by contacting the corresponding author.

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Data availability statement

Data are available upon reasonable request. Data are available by contacting the corresponding author.

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  • X @AjitSPuri1, @AdamArthurMD

  • Contributors RMK: responsible for data acquisition, data analysis, and statistical analysis. Drafted the manuscript. AP: responsible for data acquisition and analysis. JMA, ABB, VA, and MJG (gurantor)): Responsible for planning, conception and design of the study, acquisition of data, and revising the manuscript. AP, DF, ASA: Major contributions to interpretation of neuroimaging and data. Provided critical editing of the manuscript. All authors approved the final version of this manuscript to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This study was sponsored by Stryker Neurovascular and a Bits-to-Bytes grant from the Massachusetts Life Sciences Center.

  • Competing interests AP: consultant for Medtronic Neurovascular, Stryker Neurovascular, Balt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc, and Arsenal Medical; research grants from NIH, Microvention, Cerenovus, Medtronic Neurovascular, and Stryker Neurovascular; holds stocks in InNeuroCo, Agile, Perfuze, Galaxy and NTI. JMA and ABB are employees of Stryker Neurovascular. ASA: Consultant for Arsenal, Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker. Research support from Balt, Medtronic, Microvention, Penumbra and Siemens. Shareholder Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Mentice, Neurogami, Neuros, Revbio, Scientia, Serenity, Synchron, Tulavi, Vastrax, VizAI. DF: Consultant: Medtronic, Cerenovous, Microvention, Stryker, Balt USA, MENTICE-Vascular Simulations, Neurogami, Marblehead, RAPID.AI, RAPID Medical, Qapel Medical, Arsenal Medical, Phenox Medical, Scientia Medical, Perfuze; Research Support: Microvention, Stryker, Balt USA, Siemens; Scientific Advisory Boards: Scientia Medical, NVMed, Perfuze; Holds Stock in: MENTICE-Vascular Simulations, Neurogami, Marblehead, Scientia Medical, NVMed, Perfuze. MJG: Has been a consultant on a fee-per-hour basis for Alembic LLC, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, phenox GMbH, Q’Apel, Route 92 Medical, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics and Neurogami; and has received research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc LLC, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute and Xtract Medical. MJG is Associate Editor of Basic Science on the JNIS Editorial Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.