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Transcatheter Aortic Valve Implantation System: Development, Pre-Clinical and Clinical Studies, Certification

JERELO has successfully carried out the CRO-project regarding the development and launch of the first Ukrainian Transcatheter Aortic Valve Implantation System – Xpand LLC, which is extremely unique and valuable for Ukraine!

The main task for JERELO as a CRO was to provide a full range of services for the development, pre-clinical and clinical studies, and finally, for the certification of the device. Throughout the project, JERELO accurately monitored the clinical research management plan along with continuous inspection of conducted studies.

After the full cycle of development and clinical studies have been completed, the transcatheter aortic valve implantation system passed conformity assessment according to the Ukrainian Technical Regulation on Medical Devices; Therefore, the device was allowed to be used in medical practice.

After gaining the certificate, it is essential to prove the successful utility of the device via the first application in real life. Thus, successful surgery was performed on a 97-year-old lady without a slit, which was traumatic for the patient without a cardiac pump and flatline.

JERELO is proud of its successful CRO experience in the development and implementation of the device.

Please, learn more about Xpand LLC product complete life circle and stay tuned!

PRODUCT COMPLETE LIFE CIRCLE

Concept
Design

DEVICE CONCEPT & DESIGN

Medical devices assembling

Bench
tests

BENCH TESTING

We provide bench-testing according to ISO 5840-3:2013 for cardiovascular implants, cardiac valve prostheses, heart valve substitutes implanted by transcatheter techniques for hydrodynamic and durability characteristics of both, surgically implanted and transcatheter heart valve substitutes and their delivery systems.

BDC LABORATORIES HDT-500 HEART VALVE PULSE DUPLICATOR SYSTEM

We can test the full range of heart valve types, including but not limited to mechanical, stented tissue, stentless, and percutaneous valves.

BDC LABORATORIES VDT-3600I HEART VALVE DURABILITY TESTER IS AN ACCELERATED  WEAR TEST SYSTEM WHICH:

 – can evaluate both transcatheter and surgical valves to meet ISO 5840 requirements. Furthermore, the test system allows the use of silicone mock vessels in straight, curved, bifurcated or custom configurations for mounting transcatheter heart valve frames and other endovascular implants.

Animal
Study

ANIMAL STUDY

JERELO LLC is a Contract Research Organization (CRO) specializing in pre-clinical in vivo testing of a wide variety of medical devices.

Animal Study Clinic and Laboratory requirements are as follows:

  • AAALAC-accreditation of biomedical research facilities
  • Establishment of Good Laboratory Practice (GLP)

Covering over 500m2, JERELO LLC is located in an isolated area in Kiev. Facilities identified under JERELO LLC include the following:

  • Experimental unit with a surgical room that comprises video conference possibilities is designed to accommodate large research groups (65m2)
  • Veterinary clinic with clinical laboratory (110m2)
  • Animal housing facilities (25m2)
  • Necropsy laboratory for post-mortem evaluations as well as for fine excision, tissue fixation, and special processing (30m2)

EQUIPMENT CAPABILITIES

The basic set of hospital-grade equipment is available on-site:

  • Hybrid operating room with C-arm
  • Anesthesia machine and artificial lung ventilator
  • Ultrasound (including transthoracic and transesophageal echo)
  • Digital X-ray imaging
  • Hemodynamic monitoring systems (pulse oximetry, ECG with multiple pressure)
  • Automatic injectors and infusion pumps
  • Electrosurgery unit
  • Coagulation, hematological, and biochemistry analyzers
  • Custom equipment can be arranged for special needs (endoscopy, CT, MRI, cardiopulmonary bypass, etc.)

ANIMAL HOUSING

VetLab has convenient, on-site housing facilities available for short-term (acute tests, pre-&postoperative) keeping of experimental animals.

Are also provided off-site farm facilities for high volume long-term chronic animal studies.

We can accommodate and conduct research both small and large animals.

Feasibility
and Proof
of Concept

Feasibility & proof of concept

JERELO propose testing services:

  • Feasibility & proof of concept studies
  • Product development studies
  • Physician clinical bio-skills training
  • Obtaining robust data for clinical and regulatory submissions
  • Test articles: medical devices
  • Research models:
    • In vivo large and small laboratory animal models
    • Surgical & interventional models

WE CAN SUPPORT YOU WITH:

  • Study design and model selection
  • Protocol and method development
  • Research model creation
  • Medical device performance evaluation
  • Experimental surgery
  • Report writing
Clinical Study

CLINICAL TRIALS

Ukrainian clinical trial regulations have been established in compliance with the directives, guidelines, and laws of the EU, and following the Declaration of Helsinki and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines for Good Clinical Practice.

There is a close parallel between the process of seeking approval to conduct a clinical trial in Ukraine and the EU. Therefore, the procedure is quite straightforward. Applications must be submitted both to the State Administration of Ukraine on Medicines and Drugs Control (regulatory authority) and to the Local Ethics Committees (LECs) at each investigational site.

Preparation of documents Regulatory approval Average Total timeline
2-4 weeks Up to 10 weeks 10-14 weeks
Ethic committee approval
4 weeks
Manufacture

MANUFACTURE SITE

  • Clean rooms ISO class 5, 7, 8
  • Assembling
  • Testing
  • Sterilization (Liquid, Plasma, EO)
Quality
System

QUALITY SYSTEM DEVELOPMENT

  • Quality system development according to ISO 13485 and risk analysis according to ISO 14971 Risk management for medical devices

In case of any further questions, do not hesitate to contact us!

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CONTACT Us

33B, Shota Rustaveli str., Kyiv, 01033, Ukraine

+380 (95) 692 26 08

daria.abulova@jerelo.eu

Mon - Sat | 9am - 8pm

© 2020 Jerelo, LLC. | All Rights Reserved

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