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
DEVICE CONCEPT & DESIGN
Medical devices assembling
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.
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:
Covering over 500m2, JERELO LLC is located in an isolated area in Kiev. Facilities identified under JERELO LLC include the following:
The basic set of hospital-grade equipment is available on-site:
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 & proof of concept
JERELO propose testing services:
WE CAN SUPPORT YOU WITH:
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|
QUALITY SYSTEM DEVELOPMENT
In case of any further questions, do not hesitate to contact us!