Method for Combined Observation of Serial Sections of Stented Arteries Embedded in Resin by Light Microscopy and Transmission Electron Microscopy

Isobe, Atsushi; Iwatani, Kouichi; Souba, Junko; Terao, Hisako; Hagiwara, Hikoichi; Kumagai, Fumiaki; Saito, Yoshiaki; Nagano, Kasuke; Tasaki, Masako

doi:10.1177/0192623318814726

Cited by 4 publications

(2 citation statements)

References 17 publications

(16 reference statements)

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“…The most common ancillary imaging methods include high-resolution radiography (i.e., Faxitron), CT or microCT, magnetic resonance imaging (MRI) or microMRI, SEM, optical coherence tomography (OCT), fluoroscopy, and angiography. 15,23 , 34-41 Other imaging methods such as 3D electro-anatomical imaging may also be possible. The need to use an ancillary imaging method to support pathology evaluation of an implanted medical device should be determined on a case-by-case basis.…”

Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

“…The most common ancillary imaging methods include high-resolution radiography (i.e., Faxitron), CT or microCT, magnetic resonance imaging (MRI) or microMRI, SEM, optical coherence tomography (OCT), fluoroscopy, and angiography. 15,23,[34][35][36][37][38][39][40][41] Other imaging methods such as 3D electro-anatomical imaging may also be possible.…”

Section: Necropsy Procedures For Nonclinical Implant Studiesmentioning

confidence: 99%

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Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

O'Brien

Schuh²,

Wancket

et al. 2022

Toxicol Pathol

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Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology’s (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies. Implant site evaluations require highly specialized methods and analytical schemes that should be designed on a case-by-case basis to address specific study objectives. Existing STP best practice recommendations can serve as a framework when performing nonclinical studies under Good Laboratory Practices and help mitigate limitations in standards and guidances for implant evaluations (e.g., those from the International Organization for Standardization [ISO], ASTM International). This article integrates standards referenced by sponsors and regulatory bodies with practical pathology evaluation methods for implantable medical devices and combination products. The goal is to ensure the maximum accuracy and scientific relevance of pathology data acquired during a medical device or combination drug-device implantation study.

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Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

“…The most common ancillary imaging methods include high-resolution radiography (i.e., Faxitron), CT or microCT, magnetic resonance imaging (MRI) or microMRI, SEM, optical coherence tomography (OCT), fluoroscopy, and angiography. 15,23,[34][35][36][37][38][39][40][41] Other imaging methods such as 3D electro-anatomical imaging may also be possible.…”

Section: Necropsy Procedures For Nonclinical Implant Studiesmentioning

confidence: 99%