Biocompatibility and Systemic Safety of a Novel Implantable Annuloplasty Ring for the Treatment of Mitral Regurgitation in a Minipig Model

Ramot, Yuval; Rousselle, Serge; Yellin, N; Willenz, Udi; Sabag, Itai; Avner, Avi; Nyska, Abraham

doi:10.1177/0192623315627217

Cited by 10 publications

(6 citation statements)

References 33 publications

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“…23 In accordance with the increasing number of medical devices being developed, information on preclinical animal trials with such devices is also growing. [24][25][26][27][28] Specifically for fractional RF devices, it is important to evaluate the consistency and lack of fractional RF effects in the tissue adjacent to the application site, and the lack of any inflammatory reaction at the surrounding tissue. Furthermore, it is essential to observe that normal wound healing process takes place in the application site, with formation of normal skin at this site.…”

Section: Discussionmentioning

confidence: 99%

Local Tolerability and Performance Evaluation in Domestic Pigs of a Fractional Radiofrequency Device for Dermatologic Treatment

Ramot

Klaiman²,

Steiner³

et al. 2020

Toxicol Pathol

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Information on the safety of energy-based dermatological surgical devices in domestic pigs, and fractional radiofrequency (RF) devices in particular, is very limited. The aim of this study was to evaluate in a GLP-compliant study in domestic pigs the local reaction and performance of a novel fractional RF device. Five female domestic pigs were subjected to fractional RF pulses, using different energy and pulse durations and depth of penetration of the pulses. The animals were evaluated clinically and histologically at different time points (days 0, 1, 3, 7, and 14) postenergy exposure. There were no microscopic or macroscopic local adverse effects in any tested power settings, and there was time-related progressive healing, reaching complete macroscopic and microscopic healing by 7 days postapplication. As expected, there was power-related progressive increase in the incidence of ablation (destruction of skin tissue by vaporization) and coagulative necrosis of the dermis from low to high power setting. This comprehensive study, using multiple power settings (both ablative and coagulative) and several time points, will be of benefit for future studies evaluating new fractional RF devices.

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Section: Discussionmentioning

confidence: 99%

Local Tolerability and Performance Evaluation in Domestic Pigs of a Fractional Radiofrequency Device for Dermatologic Treatment

Ramot

Klaiman²,

Steiner³

et al. 2020

Toxicol Pathol

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“…Histopathological approaches have evolved overtime and state-of-the-art methods have been recently described (Tellez, Dillon, and Rousselle 2017). Methods for annuloplasty devices are also described elsewhere (Ramot et al 2016). The histology strategy for safety assessment must ensure that all biomaterials exposed to body fluids and tissue are representatively sampled and sectioned in order to assess hemocompatibility and local tissue response.…”

Section: Application Of Histology Strategies To Different Organ Systemsmentioning

confidence: 99%

Histology Strategies for Medical Implants and Interventional Device Studies

Rousselle¹,

Wicks²,

Tabb³

et al. 2019

Toxicol Pathol

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Histology of medical devices poses a variety of unique challenges. Comprehensive histologic assessment of medical devices often requires spatial context and high-quality retention of the device–tissue interface. However, the composition of many medical devices is often not amenable to traditional paraffin embedding and thus alternative specialized methodologies such as hard resin embedding must be used. Hard resin embedding requires specialized laboratory technical expertise and equipment, and the fixation techniques and resin composition used markedly impact the feasibility of immunohistochemistry. For the continuity of spatial context during histologic evaluation, additional imaging methods such as macrophotography, radiography, micro-Computerized Tomography (microCT), or magnetic resonance imaging (MRI) can be used to guide sectioning and to complement histologic findings. Although standardized approaches are scarce for medical devices, important considerations specific to medical device histology are discussed, including general specimen preparation, special considerations for devices by organ system, and the challenges of immunohistochemistry. Histologic preparation of medical devices must be thoughtful, thorough, and tailored to achieve optimal histologic outcomes for complex, valuable, and often limited implant specimens.

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“…One of the promising areas in the contemporary cardiac surgery is the development of new methods to treat pathologies in the aortic valve and thoracoabdominal aorta [1][2][3].…”

Section: Introductionmentioning

confidence: 99%

A Pig as a Model to Test Cardiovascular Devices

Rusakova,

Grankin,

Podolskaya

et al. 2024

Preprint

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Pigs are used as laboratory animals in preclinical studies on medical devices for cardiac surgery. On the one hand, the anatomy of the cardiovascular system of these animals has been well studied and acknowledged suitable for use and testing of new cardiovascular devices developed for humans. On the other hand, there are no morphometric characteristics of the aortic root and other parts of it in pigs with different weights. This can lead to difficulties in the work of researchers and even result in the death of experimental animals due to the discrepancy in the size of the implantable devices. Thus, such information is essential to improve the efficiency of surgical technologies used in the correction of aortic pathologies in its various sections. The purpose of our research is to study the anatomy of the aorta in mini-pigs, and to assess whether the size, age, and sex of animals affect the size of the main structures in their aorta. In addition, we attempted to compare the results obtained by the method of transesophageal echocardiography (TEE) and angiography. We studied 28 laboratory mini-pigs weighing from 40 to 105 kg, and then we compared our results with other studies and did not find any relationship between the external somatometric characteristics of animals and the size of their aorta. Each animal has an individual anatomy, so they are to be examined in terms of preoperative planning by any available method - echocardiography, angiography or multispiral computed tomography (MRI).

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Biocompatibility and Systemic Safety of a Novel Implantable Annuloplasty Ring for the Treatment of Mitral Regurgitation in a Minipig Model

Cited by 10 publications

References 33 publications

Local Tolerability and Performance Evaluation in Domestic Pigs of a Fractional Radiofrequency Device for Dermatologic Treatment

Local Tolerability and Performance Evaluation in Domestic Pigs of a Fractional Radiofrequency Device for Dermatologic Treatment

Histology Strategies for Medical Implants and Interventional Device Studies

A Pig as a Model to Test Cardiovascular Devices

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