Table 5.

Pre-clinical safety summary for hydrolysis mediated degradable CMC microspheres.

Authors and Year of Publication	Study Model & Duration	Test Material Information.	Ease of Use	Time to Complete Degradation of Test Material	Recanalization	Acute Complications (Vessel Rupture/Perforation)	Local and Systemic Foreign Body Reactions	Embolization Effectiveness.	Device Migration
Weng et al. (2013)	Renal Artery Rabbit Model 11 New Zealand white rabbits (Weight range 4–5 kg) 3 rabbits (group 1) received partial occlusion with BRMS-I (3, 15, and 25 mg of microspheres) To test the level of occlusion, 4 (group 2) received total occlusion with BRMS-I (10 mg/mL), and 4 more (group 3) rabbits received complete occlusion with BRMS-II Study duration: 15 min Tris-acryl gelatin microspheres (TGMS) (100–300 μm) were used as a control	2 test articles: BRMS-I and BRMS-II 2% (w/v) oxidized carboxymethylcellulose and 2% (w/v) carboxymethyl chitosan 10% oxidized carboxymethylcellulose was used in BRMS-I and 25% oxidized carboxymethylcellulose was used in BRMS-II 100–300 μm Average diameter of the microspheres was 250 μm ± 50 for BRMS-I, and 255 μm ± 45 for BRMS-II Concentration of microsphere suspension used was 1 mg/mL and 5 mg/mL for group 1, and 10 mg/mL for groups 2 and 3 all in a 5:5 saline:contrast solution	RA selectively catheterized a 4-F Cobra catheter inside which a 2.8-F microcatheter was placed Injection was “easily performed without any clogging or clumping” BRMS were deemed to be less “sticky” than TGMS BRMS-I required 8.7 mL ± 3.5 to achieve stasis and BRMS-II required 6.3 mL ± 0.8 Fluoroscopic time to achieve the endpoint was 4.5 min ± 1.6 for BRMS-I and 3.8 min ± 0.74	Not Addressed	Not addressed	Not addressed	Not addressed	Determined to achieve the desired goal of embolization similar to commercially available TGMS Mean diameter of occluded vessels found to be 197 μm ± 23 for BRMS-I, 219 μm ±36 for BRMS-II and 158 μm ±21 for TGMS	Not addressed