Minimally invasive interventions have revolutionized surgical care. As more medical device companies and individual instrument developers strive to advance these technologies, IBEX is at the forefront in helping bridge the gap between preclinical research and successfully bringing products to the market.
Interventional and minimally invasive instrument preclinical studies are essential for evaluating the safety, functionality, and effectiveness of devices used in procedures that require precision and minimal disruption to surrounding tissues. Using various animal models, researchers can test and refine devices like catheters, stents, and surgical instruments, ensuring they achieve the desired therapeutic outcomes without causing undue harm or complications.
Over the years, IBEX has built and maintained a team of exceptionally skilled veterinary surgeons, clinical consultants, and preclinical consultants who excel in supporting fast and verifiable research needs.
Whether you need custom device testing or strong documentation for regulatory submissions, IBEX has the capacity and expertise to get it done right.
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Partnering with IBEX guarantees a highly specialized approach to assessing device performance, safety, and efficacy in realistic preclinical settings. Our capabilities include neuroanursym (rabbit elastase model), cardiac lead implants, and embolics.
We offer a range of services, from early-stage feasibility testing to long-term evaluations, using advanced imaging technologies like fluoroscopy, digital radiography, and ultrasound. These technologies allow for real-time visualization and precise device placement during procedures.
Our experienced surgical team ensures that devices are deployed accurately, simulating clinical conditions to provide meaningful and reliable data on the instrument’s functionality and therapeutic outcomes. In addition to surgical and imaging capabilities, IBEX supports detailed data collection and analysis to evaluate device performance metrics such as deployment accuracy, trackability, and tissue responses.
With our decades of regulatory expertise, we can also assist with compiling comprehensive reports and documentation needed for FDA submissions, ensuring that all preclinical data aligns with regulatory standards. This full-spectrum support, from study design to regulatory guidance, enables clients to move their devices through the development process efficiently.
Contact us today to learn how to start your surgery equipment testing process with IBEX.
As an AAALAC-accredited and USDA-compliant facility, IBEX maintains the highest standards of animal care and ethical research practices. Our commitment to humane treatment and ethical integrity ensures that all studies uphold the required quality and validity.
IBEX has extensive experience conducting sophisticated interventional and minimally invasive procedures, such as embolics, vascular access device testing, and neurovascular instrument deployment.
IBEX offers a high degree of flexibility in study design, enabling clients to customize protocols and endpoints to suit the unique requirements of each device or therapy.
IBEX provides extensive pre-study planning services, including protocol development, animal model selection, and custom study design to meet specific research objectives. Our consulting services also cover regulatory strategy, helping clients determine the most efficient pathways for device testing and submission.
Our unique combination of advanced imaging capabilities, experienced surgical team, GLP compliance, and strong regulatory support makes us a leading choice for interventional and minimally invasive instrument testing.
The timeline for an interventional study depends on the complexity and objectives of the research. We work closely with clients to develop realistic timelines based on study goals and regulatory needs.
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