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. 2021 Feb 26;110(5):740–753. doi: 10.1007/s00392-021-01814-1

Table 3.

Safety summary

Assessment Summary
Angiography No stenoses present at 90 days
Animal health All animals were healthy, and no clinically significant changes were noted throughout the duration of the study
Clinical pathology (bloodwork) No clinically significant observations or abnormal trending was observed between baseline, interim (30 days) and terminal (90 days) timepoints for treated vs. control animals
Gross pathology (necropsy) No macroscopic evidence of injury to downstream or adjacent tissues (small bowel, psoas muscle, kidneys, liver, gall bladder, proximal duodenum, and head, body and tail of the pancreas)
Histopathology of the treatment area (common hepatic artery and surrounding tissues)

Histologic findings were consistent with favourable tissue responses 90 days following treatment:

• Treated vessels were completely endothelialized and did not contain any evidence of thrombus

• There was no evidence of clinically significant mural injury (e.g., arterial dissection), excessive neointima formation or occlusive process

• Repair and remodelling of vessel walls and perivascular tissue was

considered complete

• Inflammation was minimal to absent

Norepinephrine assessment

Average NE reductions at 90 days for the treated animals vs. controls

Liver: 88%

Pancreas: 78%

Duodenum: 95%

Kidney: 78%