China's First Pre-Market RCT on KeiruiChi's RuiYuan® DiaSphere® Embolic Microspheres Published in Prestigious Journal, Marking a New Era of Evidence-Based Embolization Therapy
Cardiolink Science
Vascular Interventional Medical Device Developer
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Breaking the Ice: The First Pre-Market Launch of China's Tumor Embolization MicrospheresPublication of RCT Study
Cardiolink Science's independently developed Ruiyuan®DiaSphere®Embolic Microspheres Recently Reach Another Milestone——The research findings of its pre-market randomized controlled trial (RCT) were published online for the first time in an authoritative journal. As the first in China...Embolic microspheres for pre-market RCT clinical studies,Rui Yuan®DiaSphere®Verified the safety and efficacy of the product according to the gold standard of evidence-based medicine, filling the gap in pre-market randomized controlled trials (RCT) research for high-end medical devices in China's embolization intervention field, and providing sufficient evidence-based support for its clinical practice.
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Dual Certification: Recommended by Guidelines+RCT Evidence Builds the Cornerstone of Clinical Decision-Making
Rui Yuan®DiaSphere®Microspheres are Cardiolink Science's simulation of biological cell structures, constructed through the patented technologies of "GCL Gradient Crosslinking" and "IPN Molecular Reticular Interpenetration" to form precise "Biomimetic Core-Shell" embolic microspheres (Accurate Nuclear-shell Spheres, ANS).睿渊®DiaSphere®With excellent mechanical properties, fast drug loading, and stable drug release, it achieves "evidence-based dual certification" through superior performance:
Academic Height: Forward-lookingRCT study peer-reviewed, confirmed withDiaSphere®Embolization microspheres for TACE in the treatment of HCC show good short-term efficacy and safety, and are worthy of clinical promotion.
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Clinical Breadth: Ruiyuan®DiaSphere®Embolic microspheres have been written into "2023 Chinese Clinical Practice Guidelines for Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma, becoming the embolic microspheres recommended by the guidelines and verified by pre-market RCT. The dual-track evidence system injects strong "evidence momentum" into physician decision-making.
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Evidence-Based: Cardiolink Science's Evidence Philosophy
Cardiolink Science always takes a highly responsible attitude towards patients' lives, and is committed to providing sufficient evidence for products through prospective clinical research:
▶ In collaboration with multiple authoritative medical centers, providing solid evidence-based support for product applications through clinical research;
▶ Build a three-level evidence chain of "basic research - clinical trials - real-world data" to continuously verify the efficacy and safety of products;
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Cardiolink Science:Therapy Reading Drives the Paradigm Shift in Embolization Treatment
Based on"Therapy Reading" Core Concept: Cardiolink Science Achieves Two Major Breakthroughs in the Embolization Field
• Precision Embolization: Utilizing a series of precision bionic core-shell embolic microspheres, combined with the Cardiolink Science precision microcatheter and micro guidewire delivery system, to promote the widespread adoption of precision embolization technology and enhance embolization treatment outcomes.
• Pan-organ Expansion: Breaking through the traditional boundaries of liver cancer treatment, driving embolization intervention from "specific organ treatment" to a strategic upgrade of "pan-organ function regulation," providing more support for symptom relief and quality of life improvement for patients.
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The Light of Evidence-Based Medicine: Illuminating a New Journey in Precision Intervention
DiaSphere®Microsphere RCT StudyThe publication not only marks China's embolic microspheres entering the forefront of evidence-based development but also confirms Cardiolink Science's hardcore R&D logic driven by clinical needs. In the future, the company will continue to deepen its full-stack product layout, using evidence-based medicine as the anchor, leading interventional treatment from lesion removal into a precise era of organ function reconstruction.