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.
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.
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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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