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O-028 The intrasaccular seal© device: improved flexibility and healing
  1. A Kraitem1,
  2. M Gounis1,
  3. Z Vardar1,
  4. R King1,
  5. E Langan1,
  6. T Wolfe2,
  7. A Badruddin3,
  8. E Periera4,
  9. B Follmer5,
  10. A Rosqueta5,
  11. O Zaidat6
  1. 1Radiology, University of Massachusetts, Worcester, MA
  2. 2Aurora Neuroscience Innovation Institute, Aurora Health, Milwaukee, WI
  3. 3Neurology, Community Hospital, Munster, IN
  4. 4Vascular and Interventional Radiology, Biscayne Medical Arts Center, Miami, FL
  5. 5RandD, Galaxy Therapeutics, Broofield, WI
  6. 6Endovascular Neurosurgery and Stroke, St Vincent Medical Center, Toledo, OH


Background The new generation of intrasaccular flow disruptors offers several potential advantages in aneurysm treatment.1 2 However, questions regarding risks for thromboembolic complications3 4 and long-term treatment durability remain. We study the safety and effectiveness of three Galaxy Therapeutics Seal© intrasaccular prototypes: A, B, and C (Galaxy Therapeutics LLC, Brookfield, WI).

Methods Aneurysms were created in thirteen rabbits and one of 3 Seal devices were implanted. High frequency optical coherence tomography (HF-OCT) and Digital Subtraction Angiography (DSA) was performed 4- and 12-weeks post-implant. After 12 weeks, the parent vessel and the aneurysm were explanted for histological analysis. One rabbit developed symptoms consistent with a lumbar spine injury and was euthanized and explanted at day 56.

Results 12-week DSA and OCT images demonstrated 8 animals had a satisfactory aneurysm occlusion (group 1: complete blood flow disruption or contrast filling in marker recess) and 4 into group 2 (residual neck or aneurysm). The percentage of neointimal coverage of the device at four-weeks was greater for group 1 (78 ±22.6 %) than for group 2 (37 ±4.7 %) (p= 0.006) which persisted at 12-weeks (87.5± 14 % vs. 41± 3.1 % respectively; p= 0.004). There was no statistical difference between groups 1 and 2 in either baseline neck gap areas (0.8± 0.64 mm2 vs. 2.6± 1.42 mm2, respectively; p= 0.808) nor in baseline neck gap volumes (26± 26 mm3 vs. 113.11± 134.17 mm3, respectively; p= 0.361). Representative examples of pathology are shown in the figure 1.

Abstract O-028 Figure 1 H&E stains for the three prototypes (A), (B), and (C) 12-weeks following implant. Solid line=approximate aneurysm neck. Arrowhead = mature and stable neointima covering device; F= fibrovascular tissue partially filling the fundus; A: asterisk = sequestered cystic space within the fundus (not connected to parent vessel). B: arrow=fibrin thrombus in parent artery recess at neck

Conclusion Preliminary evidence in this preclinical study highlight advantages of a new generation of intrasaccular aneurysm embolization technology in terms of flexibility and optimization of healing features, particularly in the A and C cohorts.


  1. Radiology 2014;273:194–201.

  2. J Neurointerv Surg 2019;11:1150–1154.

  3. World Neurosurg 2018;109:e183–e193.

  4. J Neurointerv Surg 2018;10:553–559.

Disclosures A. Kraitem: None. M. Gounis: 1; C; Research grant to institution to fund experiments by Galaxy Therapeutics. Z. Vardar: None. R. King: None. E. Langan: None. T. Wolfe: 4; C; Founder, Galaxy Therapeutics. A. Badruddin: 4; C; Founder, Galaxy Therapeutics. E. Periera: 4; C; Founder, Galaxy Therapeutics. B. Follmer: 5; C; Galaxy Therapeutics. A. Rosqueta: 5; C; Galaxy Therapeutics. O. Zaidat: 4; C; Founder, Galaxy Therapeutics.

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