Strong capability for vascular clinical studies with unique access to world-renowned Vascular lab and angiography core laboratory.
Book a ConsultationA vascular medical device is used during open surgery and endovascular techniques to control, diagnose, monitor, or correct disease or injury. It encompasses cardiovascular, peripheral vascular, and neurovascular anatomy.
Our team specializes in implants, endovascular prosthesis, and stents intended for use in arteries and veins. We collaborate with in-house clinicians specialized in endovascular surgery and clinical investigation.
Ensuring patient safety and data integrity through periodic risk-benefit evaluation.
Cardiovascular medicine is increasingly dictated by evidence-based guidelines. Our Center for Advanced Imaging assesses the imaging component of trials to ensure they are reproducible and yield the best outcomes.
intended claims on safety and performance were not sufficiently supported by existing evidence. A comprehensive PMCF study was required under EU MDR Chapter VI and ISO 14155:2020.
Multicentre RWE study. 250-300 subjects evaluated across 8 sites. Data retrieved from medical charts from baseline to 3 years post-surgery.
✓ Accepted by the Notified Body
✓ Representative patient population
✓ Validated long-term durability
Support clinical trials in EU, UK, Australia, and Japan with one partner.
Cutting-edge imaging technology in collaboration with CORRIB Lab.
Clinical project managers specialized in complex Vascular trials.
Dedicated registered nurses and technical specialists for research.
Successful track record in Data Safety and Monitoring Board management.
Proprietary EDC, ePRO, and e-consent technology for vascular data.
Contact our vascular medical device experts to discuss your clinical trial needs and discover how ECLEVAR MEDTECH can support your regulatory success.
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