Clinical Neuroradiology

, Volume 27, Issue 3, pp 335–343 | Cite as

The Derivo Embolization Device, a Second-Generation Flow Diverter for the Treatment of Intracranial Aneurysms, Evaluated in an Elastase-Induced Aneurysm Model

  • D. Ley
  • R. Mühl-Benninghaus
  • U. Yilmaz
  • H. Körner
  • G. F. M. Cattaneo
  • W. Mailänder
  • Y-J. Kim
  • B. Scheller
  • W. Reith
  • A. SimgenEmail author
Original Article



In recent years, flow diverters have provided a promising alternative to treat complex intracranial aneurysms. In this study, we compare a second-generation flow-diverting device (Derivo Embolization Device) with its prototype flow diverter, in the treatment of elastase-induced aneurysms in New Zealand white rabbits.


The Derivo Embolization Device is a self-expanding stent consisting of 48 nitinol wires. The device was implanted across the necks of 17 elastase-induced aneurysms in New Zealand white rabbits. One additional device was implanted in the abdominal aorta of each animal covering the origin of lumbar arteries. Follow-up was performed after 3 months (n = 8) and 6 months (n = 9) under continuous double antiplatelet therapy. Statuses of angiographic and histological aneurysm occlusion as well as patency of branch arteries and neointimal growth were evaluated and compared with its prototype flow diverter.


The Derivo Embolization Device provided advanced visibility and flexibility, which led to more accurate navigation and placement. Complete aneurysm occlusion rates were noted in 15 cases (88 %), respectively, compared with 5 cases (28 %) with the first-generation device (p = 0.001). Neointimal growth and diameter stenosis were significantly less with the Derivo Embolization Device and declining after 6 months follow-up in the abdominal aorta. Extreme device oversizing led to distal occlusion of the parent vessel in three cases. Covered branch arteries remained patent throughout the entire period of observation.


The Derivo Embolization Device provides excellent occlusion of elastase-induced aneurysms while preserving branch arteries.


Digital Subtraction Angiography Abdominal Aorta Subclavian Artery Intracranial Aneurysm Diameter Stenosis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Flow Re-Direction Endoluminal Device


Flow Diverter


Digital Subtraction Angiography


Abdominal Aorta


Subclavian Artery


Brachiocephalic Trunk


Internal Carotid Artery


Pipeline Embolization Device


SILK Flow Diverter



This study was supported in part by a research grant of the BMWi (German Ministry of Economic Affairs and Energy, Grant number: KF2335801WL9).

We would like to thank the Head of the Department of Experimental Surgery, Prof. Menger, and his team for supporting this study.

Ethical Standards

We declare that our animal studies have been approved by the (ethics committee of the Saarland University) and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.


Parts of this study have been published as an oral poster presentation at the meeting of the German society of neuroradiology (DGNR) in Cologne, Germany in October 2013 and as an oral presentation at the 20th Symposium Neuroradiologicum Istanbul, Turkey in September 2014.

Conflict of Interest

This study was funded by Acandis GmbH, Pforzheim, Germany. Giorgio Franco Maria Cattaneo and Werner Mailänder, engineers at the company, served as proctors during this study.


  1. 1.
    Kallmes DF, Ding Y-H, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke. 2007;38(8):2346–52.CrossRefPubMedGoogle Scholar
  2. 2.
    Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A second-generation, endoluminal, flow-disrupting device for treatment of saccular aneurysms. AJNR Am J Neuroradiol. 2009;30:1153–8.CrossRefPubMedGoogle Scholar
  3. 3.
    Sadasivan C, Cesar L, Seong J, Rakian A, Hao Q, Tio FO, Wakhloo AK, Lieber BB. An original flow diversion device for the treatment of intracranial aneurysms: evaluation in the rabbit elastase-induced model. Stroke. 2009;40(3):952–8.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS. Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol. 2012;33(8):1436–46.CrossRefPubMedGoogle Scholar
  5. 5.
    Berge J, Biondi A, Machi P, Brunel H, Pierot L, Gabrillargues J, Kadziolka K, Barreau X, Dousset V, Bonafé A. Flow-diverter silk stent for the treatment of intracranial aneurysms: 1-year follow-up in a multicenter study. AJNR Am J Neuroradiol. 2012;33(6):1150–5.CrossRefPubMedGoogle Scholar
  6. 6.
    Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013;267(3):858–68.CrossRefPubMedGoogle Scholar
  7. 7.
    Puffer RC, Piano M, Lanzino G, Valvassori L, Kallmes DF, Quilici L, Cloft HJ, Boccardi E. Treatment of cavernous sinus aneurysms with flow diversion: results in 44 patients. AJNR Am J Neuroradiol. 2014;35:948–51.CrossRefPubMedGoogle Scholar
  8. 8.
    Diaz O, Gist TL, Manjarez G, Orozco F, Almeida R. Treatment of 14 intracranial aneurysms with the FRED system. J Neurointerv Surg. 2013;0:1–4.Google Scholar
  9. 9.
    Murthy SB, Shah S, Venkatasubba Rao CP, Bershad EM, Suarez JI. Treatment of unruptured intracranial aneurysms with the pipeline embolization device. J Clin Neurosci. 2014;21(1):6–11.CrossRefPubMedGoogle Scholar
  10. 10.
    Kulcsár Z, Ernemann U, Wetzel SG, Bock A, Goericke S, Panagiotopoulos V, Forsting M, Ruefenacht DA, Wanke I. High-profile flow diverter (silk) implantation in the basilar artery: efficacy in the treatment of aneurysms and the role of the perforators. Stroke. 2010;41(8):1690–6.CrossRefPubMedGoogle Scholar
  11. 11.
    van Rooij WJ, Sluzewski M. Perforator infarction after placement of a pipeline flow-diverting stent for an unruptured A1 aneurysm. AJNR Am J Neuroradiol. 2010;31(4):E43–4.CrossRefPubMedGoogle Scholar
  12. 12.
    Maimon S, Gonen L, Nossek E, Strauss I, Levite R, Ram Z. Treatment of intra-cranial aneurysms with the SILK flow diverter: 2 years’ experience with 28 patients at a single center. Acta Neurochir (Wein). 2012;154(6):979–87.CrossRefGoogle Scholar
  13. 13.
    Tan LA, Keigher KM, Munich SA, Moftakhar R, Lopes DK. Thromboembolic complications with Pipeline Embolization Device placement: impact of procedure time, number of stents and pre-procedure P2Y12 reaction unit (PRU) value. J Neurointerv Surg. 2015;7(3):217–21.Google Scholar
  14. 14.
    Murthy SB, Shah S, Shastri A, Venkatasubba Rao CP, Bershad EM, Suarez JI. The SILK flow diverter in the treatment of intracranial aneurysms. J Clin Neurosci. 2014;21(2):203–6.CrossRefPubMedGoogle Scholar
  15. 15.
    Kulcsár Z, Houdart E, Bonafé A, Parker G, Millar J, Goddard AJ, Renowden S, Gál G, Turowski B, Mitchell K, Gray F, Rodriguez M, van den Berg R, Gruber A, Desal H, Wanke I, Rüfenacht DA. Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment. AJNR Am J Neuroradiol. 2011;32(1):20–5.PubMedGoogle Scholar
  16. 16.
    Turowski B, Macht S, Kulcsár Z, Hänggi D, Stummer W. Early fatal hemorrhage after endovascular cerebral aneurysm treatment with a flow diverter (SILK-Stent): do we need to rethink our concepts? Neuroradiology. 2011;53(1):37–41.CrossRefPubMedGoogle Scholar
  17. 17.
    Cebral JR, Mut F, Raschi M, Scrivano E, Ceratto R, Lylyk P, Putman CM. Aneurysm rupture following treatment with flow-diverting stents: computational hemodynamics analysis of treatment. AJNR Am J Neuroradiol. 2011;32(1):27–33.PubMedGoogle Scholar
  18. 18.
    Hampton T, Walsh D, Tolias C, Fiorella D. Mural destabilization after aneurysm treatment with a flow-diverting device: a report of two cases. J Neurointerv Surg. 2011;3(2):167–71.CrossRefPubMedGoogle Scholar
  19. 19.
    Clarençon F, Di Maria F, Biondi A, Chiras J, Sourour NA. Distant and delayed (> 7 days) hemorrhage after treatment by flow-diverter stents in intracranial aneurysms: a rare but potentially serious complication. AJNR Am J Neuroradiol. 2013;34(7):E81–2.CrossRefPubMedGoogle Scholar
  20. 20.
    Darsaut TE, Rayner-Hartley E, Makoyeva A, Salazkin I, Berthelet F, Raymond J. Aneurysm rupture after endovascular flow diversion: the possible role of persistent flows through the transition zone associated with device deformation. Interv Neuroradiol. 2013;19(2):180–5.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    Tomas C, Benaissa A, Herbreteau D, Kadziolka K, Pierot L. Delayed ipsilateral parenchymal hemorrhage following treatment of intracranial aneurysms with flow diverter. Neuroradiology. 2014;56(2):155–61.CrossRefPubMedGoogle Scholar
  22. 22.
    Fiorella D, Hsu D, Woo HH, Tarr RW, Nelson PK. Very late thrombosis of a pipeline embolization device construct. Neurosurgery. 2010;67:onsE313–4.PubMedGoogle Scholar
  23. 23.
    Fischer S, Vajda Z, Aguilar Perez M, Schmid E, Hopf N, Bäzner H, Henkes H. Pipeline embolization device (PED) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections. Neuroradiology. 2012;54(4):369–82.CrossRefPubMedGoogle Scholar
  24. 24.
    Cohen JE, Gomori JM, Moscovici S, Leker RR, Itshayek E. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents. J Clin Neurosci. 2014;21:1116–22.CrossRefPubMedGoogle Scholar
  25. 25.
    Simgen A, Ley D, Roth C, Yilmaz U, Körner H, Mühl-Benninghaus R, Kim YJ, Scheller B, Reith W. Evaluation of a newly designed flow diverter for the treatment of intracranial aneurysms in an elastase-induced aneurysm model, in New Zealand white rabbits. Neuroradiology. 2014;56(2):129–37.CrossRefPubMedGoogle Scholar
  26. 26.
    Cloft HJ, Altes TA, Marx WF, Raible RJ, Hudson SB, Helm GA, Mandell JW, Jensen ME, Dion JE, Kallmes DF. Endovascular creation of an in vivo bifurcation aneurysm model in rabbits. Radiology. 1999;213(1):223–8.CrossRefPubMedGoogle Scholar
  27. 27.
    Kamran M, Yarnold J, Grunwald IQ, Byrne JV. Assessment of angiographic outcomes after flow diversion treatment of intracranial aneurysms: a new grading schema. Neuroradiology. 2011;53(7):501–8.CrossRefPubMedGoogle Scholar
  28. 28.
    Cremers B, Kelsch B, Clever YP, Hattangadi N, Mahnkopf D, Speck U, Taupitz M, Scheller B. Inhibition of neointimal proliferation after bare metal stent implantation with low-pressure drug delivery using a paclitaxel-coated balloon in porcine coronary arteries. Clin Res Cardiol. 2012;101(5):385–91.CrossRefPubMedGoogle Scholar
  29. 29.
    Briganti F, Napoli M, Tortora F, Solari D, Bergui M, Boccardi E, Cagliari E, Castellan L, Causin F, Ciceri E, Cirillo L, De Blasi R, Delehaye L, Di Paola F, Fontana A, Gasparotti R, Guidetti G, Divenuto I, Iannucci G, Isalberti M, Leonardi M, Lupo F, Mangiafico S, Manto A, Menozzi R, Muto M, Nuzzi NP, Papa R, Petralia B, Piano M, Resta M, Padolecchia R, Saletti A, Sirabella G, Bolgè LP. Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications—a retrospective data analysis. Neuroradiology. 2012;54(10):1145–52.CrossRefPubMedGoogle Scholar
  30. 30.
    Gross BA, Frerichs KU. Stent usage in the treatment of intracranial aneurysms: past, present and future. J Neurol Neurosurg Psychiatry. 2013;84(3):244–53.CrossRefPubMedGoogle Scholar
  31. 31.
    Asakura M, Ueda Y, Nanto S, Hirayama A, Adachi T, Kitakaze M, Hori M, Kodama K. Remodeling of in-stent neointima, which became thinner and transparent over 3 years: serial angiographic and angioscopic follow-up. Circulation. 1998;97(20):2003–6.CrossRefPubMedGoogle Scholar
  32. 32.
    Dai D, Ding YH, Kadirvel R, Rad AE, Lewis DA, Kallmes DF. Patency of branches after coverage with multiple telescoping flow-diverter devices: an in vivo study in rabbits. AJNR Am J Neuroradiol. 2012;33(1):171–4.CrossRefPubMedGoogle Scholar
  33. 33.
    Dai D, Ding YH, Kadirvel R, Lewis DA, Cloft HJ, Kallmes DF. Bone formation in elastase-induced rabbit aneurysms embolized with platinum coils: report of 2 cases. AJNR Am J Neuroradiol. 2007;28(6):1176–8.CrossRefPubMedGoogle Scholar
  34. 34.
    Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015;40(4):437–43.CrossRefPubMedGoogle Scholar
  35. 35.
    Chappé J-M, Martin N, Lintymer J, Sthal F, Terwagne G, Takadoum J. Titanium oxynitride thin films sputter deposited by the reactive gas pulsing process. Appl Surf Sci. 2007;253:5312–6.CrossRefGoogle Scholar
  36. 36.
    Kocer N, Islak C, Kizilkilic O, Kocak B, Saglam M, Tureci E. Flow Re-direction Endoluminal Device in treatment of cerebral aneurysms: initial experience with short-term follow-up results. J Neurosurg. 2014;120(5):1158–71.Google Scholar
  37. 37.
    Pereira VM, Kelly M, Vega P, Murias E, Yilmaz H, Erceg G, Pellaton A, Lovblad KO, Krings T. New Pipeline Flex device: initial experience and technical nuances. J Neurointerv Surg. 2015;7(12):920–5.CrossRefPubMedGoogle Scholar
  38. 38.
    Briganti F, Leone G, Marseglia M, Cicala D, Caranci F, Maiuri F. p64 flow modulation device in the treatment of intracranial aneurysms: initial experience and technical aspects. J Neurointerv Surg. 2015 Apr 20. [Epub ahead of print]Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • D. Ley
    • 1
  • R. Mühl-Benninghaus
    • 1
  • U. Yilmaz
    • 1
  • H. Körner
    • 1
  • G. F. M. Cattaneo
    • 2
  • W. Mailänder
    • 2
  • Y-J. Kim
    • 3
  • B. Scheller
    • 4
  • W. Reith
    • 1
  • A. Simgen
    • 1
    Email author
  1. 1.Departments of NeuroradiologySaarland University HospitalHomburg/SaarGermany
  2. 2.Acandis GmbHPforzheimGermany
  3. 3.Departments of PathologySaarland University HospitalHomburg/SaarGermany
  4. 4.Departments of CardiologySaarland University HospitalHomburg/SaarGermany

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