Animal model for preclinical investigation of arterial implants

N.Yu Orlinskaya1,  MD, professor.   E-mail: orlinskaya@rambler.ru
E.G. Sharabrin1, doctor of medical sciences, professor.  E-mail: sharabrin@mail.ru
D.G. Chatkin1,  X-ray endovascular diagnosis and treatment doctor, cardiovascular surgeon.   
D.V. Davydenko1, Researcher, PhD in Biological sciences FSBEI HE «Privolzhsky Research Medical University» of the Ministry of Health of the Russian Federation, Nizhny Novgorod. Email: dav-dina@yandex.ru
N.E Rassykhin1,
A.S. Grishin1,
А.В. Drugov2, Head of the New Business Development Department. E-mail: a.drugov@stentex.ru
М.Е. Popov2, General Director. E-mail: m.popov@stentex.ru
A.I. Prostyakova3, PhD, researcher. E-mail: prostyakova@gmai.com

1Federal State Budgetary Educational Institution of Higher Education «Privolzhsky Research Medical University» of the Ministry of Health of the 603005, Russian Federation, Nizny Novgorod, square Minina i Pozharskogo 10/1;

2BIOSTEN LLC, 121205, Moscow, the territory of the Skolkovo Innovation Center. Nobel, 1;

3Shemykin-Ovchinnikov Institute of Bioorganic chemistry of the Russian Academy of Science, 117997, Moscow, ulitsa Miklukho-Maklaya, 16/10

E-mail: prostyakova@gmail.com

Abstract

According to international recommendations and practice, preclinical animal testing is a mandatory step preceding the start of clinical trials in the case of high-risk medical devices and implantable medical devices. One of the most common such products is arterial implants, and in particular, coronary stents (3rd class of risk according to the Rules for the classification of medical devices, depending on the potential risk of use).

Currently, dozens, if not hundreds, of different stent models are available on the market, and new modifications appear every year: the material and design of stents, drugs, polymers providing controlled kinetics of drug release change. Since stents belong to products of the highest risk class, each newly developed product must undergo a full cycle of preclinical and clinical trials, confirming its safety and effectiveness. At the same time, it should be noted that the design of both clinical and preclinical studies directly depends on the scope and type of product, but at the moment in the Russian Federation there are no detailed recommendations for the selection of model objects, methods and procedures for conducting preclinical tests of coronary stents in vivo.

Objective: to propose and test an animal model for the subsequent preclinical testing of endovascular implants (stents).

The model is a surgical operation to install an endovascular implant into the animal's bloodstream. The external iliac artery of male Chinchilla rabbits was used as an experimental biomodel for implantation of stents. The intervention was performed through the right common carotid artery. The stages of the operation, technical methods are analyzed, possible difficulties and complications of access are evaluated.

It has been shown that the iliac artery of the rabbit with access to the vessels through the carotid artery is an inexpensive, convenient and safe biomodel for preclinical testing of endovascular implants. To use the technique, specialized tools are not required: standard medical devices are used to perform endovascular interventions (introductors, guides, indeflatory, diagnostic catheters). Sewing the puncture hole of the common carotid artery provides reliable hemostasis and prevention of stroke in laboratory animals, increases the survival of animals after surgery and does not significantly extend the manipulation and time of anesthesia.

The proposed animal model and intervention technique showed good reproducibility and can be recommended for use in preclinical trials of endovascular implants (stents) in the territory of the Russian Federation.

Full text available in Russain only.

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