O-028 The intrasaccular seal©device: improved flexibility and healing
Afif M. Kraitema, Matthew J. Gounisa, Zeynep Vardara, Robert M Kinga, Erin T. Langana, Thomas J. Wolfeb, Aamir Badruddinc, E Perierad, B Follmere, Arturo S Rosquetae, Osama O. Zaidatf
- aRadiology, University of Massachusetts, Worcester, MA
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Abstract
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. References Radiology 2014;273:194–201. J Neurointerv Surg 2019;11:1150–1154. World Neurosurg 2018;109:e183–e193. 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.
TL;DRPreliminary 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. (Semantic Scholar)