Calibrated Bioresorbable Microspheres: A Preliminary Study on the Level of Occlusion and Arterial Distribution in a Rabbit Kidney Model

Weng, Lei; Rusten, Myra; Talaie, Reza; Hairani, Mehrdad; Rosener, Nikolaus K.; Golzarian, Jafar

doi:10.1016/j.jvir.2013.06.009

Cited by 11 publications

(14 citation statements)

References 25 publications

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“…The presence of infarcts confirmed that this material achieves the desired goal of embolization similar to commercially available nonresorbable embolic materials (11,14). Similar to previous studies (15), the BRMS in rabbits sacrificed on day 0 were identified in the interlobar and arcuate arteries, although the level of occlusion changed as the resorption continued. Ohta et al (13) described a similar phenomenon in which gelatin microspheres > 100 μm progressively migrated from the interlobar arteries to interlobular arteries, which was much faster than BRMS.…”

Section: Discussionsupporting

confidence: 86%

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Calibrated Bioresorbable Microspheres as an Embolic Agent: An Experimental Study in a Rabbit Renal Model

Weng

Seelig

Rostamzadeh

et al. 2015

Journal of Vascular and Interventional Radiology

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Purpose To evaluate the time frame of resorption and tissue response of newly developed bioresorbable microspheres (BRMS) and vessel recanalization after renal embolization. Materials and Methods Embolization of lower poles of kidneys of 20 adult rabbits was performed with BRMS (300–500 μm). Two rabbits were sacrificed immediately after embolization (day 0). Three rabbits were sacrificed after follow-up angiography at 3, 7, 10, 14, 21, and 30 days. The pathologic changes in the renal parenchyma, BRMS degradation, and vessel recanalization were evaluated histologically and angiographically. Results Embolization procedures were successfully performed, and all animals survived without complication. Infarcts were observed in all kidneys that received embolization harvested after day 0. Moderate degradation of BRMS (score = 1.07 ± 0.06) was observed by day 3. Of BRMS, 95% were resorbed before day 10 with scant BRMS materials remaining in the arteries at later time points. Partial vessel recanalization was observed by angiography starting on day 3, whereas new capillary formation was first identified histologically on day 7. Vascular inflammation associated with BRMS consisted of acute, heterophilic infiltrate at earlier time points (day 3 to day 10); this was resolved with the resorption of BRMS. Inflammation and fibrosis within infarcted regions were consistent with progression of infarction. Conclusions BRMS were bioresorbable in vivo, and most BRMS were resorbed before day 10 with a mild tissue reaction. Vessel recanalization occurred secondary to the resorption of BRMS.

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Section: Discussionsupporting

confidence: 86%

“…Compared with nonresorbable microspheres, BRMS are bioresorbable, while still achieving a similar level of occlusion (15). Owing to their resorbability, it is reasonable to anticipate that the inflammation associated with BRMS is inherently self-limiting.…”

Section: Discussionmentioning

confidence: 99%

Calibrated Bioresorbable Microspheres as an Embolic Agent: An Experimental Study in a Rabbit Renal Model

Weng

Seelig

Rostamzadeh

et al. 2015

Journal of Vascular and Interventional Radiology

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“…2.7 | Microsphere penetration in a rabbit renal artery model A renal penetration model was used to determine the comparative extent of LUMI40-90 and LUMI70-150 microsphere penetration into the well-defined vascular tree within the kidney. This model has been well established in previous evaluations of embolic microsphere distribution in sheep (Laurent et al, 2006;Verret et al, 2011), swine (Maeda et al, 2013;Stampfl et al, 2009), and rabbits (Weng et al, 2013). As there is some overlap in the LUMI40-90 and LUMI70-150 size ranges (40-90 and 70-150 μm) arterial penetration was evaluated by renal artery embolization in New Zealand White rabbits where the smaller vessels were more suitable for detecting a separation between the two size ranges.…”

Section: Biocompatibility Studiesmentioning

confidence: 99%

Handling and performance characteristics of a new small caliber radiopaque embolic microsphere

et al. 2020

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The in vitro and in vivo handling and performance characteristics of a small caliber radiopaque embolic microsphere, 40–90 μm DC Bead LUMI™ (LUMI40‐90), were studied. Microsphere drug loading and elution and effects on size, suspension, and microcatheter delivery were evaluated using established in vitro methodologies. In vivo evaluations of vascular penetration (rabbit renal artery embolization), long‐term biocompatibility and X‐ray imaging properties, pharmacokinetics and local tissue effects of both doxorubicin (Dox) and irinotecan (Iri) loaded microspheres (swine hepatic artery embolization) were conducted. Compared to 70–150 μm DC Bead LUMI (LUMI70‐150), LUMI40‐90 averaged 70 μm versus 100 μm, which was unchanged upon drug loading. Handling, suspension, and microsphere delivery studies were successfully performed. Dox loading was faster (20 min) and Iri equivalent (<10 min) while drug elution rates were similar. Contrast suspension times were longer with no delivery complications. Vascular penetration was statistically greater (rabbit) with no unexpected adverse safety findings (swine). Microspheres ± drug were visible under X‐ray imaging (CT) at 90 days. Peak plasma drug levels and area under the curve were greater for LUMI40‐90 compared to LUMI70‐150 but comparable to 70–150 μm DC BeadM1™ (DC70‐150). Local tissue effects showed extensive hepatic necrosis for Dox, whereas Iri displayed lower toxicity with more pronounced lobar fibrosis. LUMI40‐90 remains suspended for longer and have greater vessel penetration compared to the other DC Bead LUMI sizes and are similarly highly biocompatible with long‐term visibility under X‐ray imaging. Drug loading is equivalent or faster with pharmacokinetics similar to DC70‐150 for both Dox and Iri.

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“…Only one of these papers met the inclusion criteria, the remainder of articles were substantially focused on drug-carrying materials and neuroprotective effects in ischemic brain injury. The paper meeting the inclusion criteria was published by Weng et al in 2013 [ 42 ] and provides a detailed analysis of the safety and efficacy of CMC-CCN-based microspheres for TAE, which they call ‘bioresorbable microspheres’ (‘BRMS’). This paper used a renal artery rabbit model over a period of 15 min.…”

Section: Current State Of the Artmentioning

confidence: 99%

Advances in Degradable Embolic Microspheres: A State of the Art Review

Doucet

Kiri²,

O'Connell³

et al. 2018

JFB

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Considerable efforts have been placed on the development of degradable microspheres for use in transarterial embolization indications. Using the guidance of the U.S. Food and Drug Administration (FDA) special controls document for the preclinical evaluation of vascular embolization devices, this review consolidates all relevant data pertaining to novel degradable microsphere technologies for bland embolization into a single reference. This review emphasizes intended use, chemical composition, degradative mechanisms, and pre-clinical safety, efficacy, and performance, while summarizing the key advantages and disadvantages for each degradable technology that is currently under development for transarterial embolization. This review is intended to provide an inclusive reference for clinicians that may facilitate an understanding of clinical and technical concepts related to this field of interventional radiology. For materials scientists, this review highlights innovative devices and current evaluation methodologies (i.e., preclinical models), and is designed to be instructive in the development of innovative/new technologies and evaluation methodologies.

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Calibrated Bioresorbable Microspheres: A Preliminary Study on the Level of Occlusion and Arterial Distribution in a Rabbit Kidney Model

Cited by 11 publications

References 25 publications

Calibrated Bioresorbable Microspheres as an Embolic Agent: An Experimental Study in a Rabbit Renal Model

Calibrated Bioresorbable Microspheres as an Embolic Agent: An Experimental Study in a Rabbit Renal Model

Handling and performance characteristics of a new small caliber radiopaque embolic microsphere

Advances in Degradable Embolic Microspheres: A State of the Art Review

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