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Posted: April 29, 2025 | News
CitraFlow: The Solution for Catheter-Related Bacteraemia and Clotting of Catheters
Amsino, in collaboration with its subsidiary MedXL, a leading manufacturer of pre-filled syringes, hosted an in-depth seminar on CitraFlow™ sodium citrate syringes on April 10, 2025, during the CMEF.
The seminar highlighted the significance of CitraFlow prefilled syringes for catheters, particularly regarding bacterial contamination and dialysis catheter maintenance.
The seminar explained the benefits of the various concentrations of CitraFlow—CitraFlow 4%, CitraFlow 30%, and CitraFlow 46.7%—and the reduction of CLABSI (Central Line–Associated Blood Stream Infections).
They also reviewed various market segments beyond the hemodialysis segment, such as intensive care, hematology, and oncology.
MedXL shared the latest scientific evidence of CitraFlow that was recently published.
Jeroen Fietjé chaired the seminar, providing comprehensive support throughout the event.
Paul Parisien, President of MedXL Inc., showcased MedXL's robust corporate capabilities through a series of videos and images. MedXL is renowned for manufacturing a diverse range of prefilled syringes (PFS) that are reliable, safe, and secure. The company adheres to the principle of designing and manufacturing medical products that save lives. MedXL produces and distributes pre-filled syringes globally, leveraging both small-batch and large-scale production to meet unique customer requirements. MedXL also maintains ISO 13485-certified quality systems and offers a wide array of products across multiple categories.
Jeroen Fietjé, General Manager of MedXL Europe BV, presented extensive research and experimental data on CitraFlow. With an 85% market share in the UK, CitraFlow can reduce treatment costs by 58% compared to heparin and decrease catheter-related infections in hemodialysis by 75%. Clinical data demonstrated the benefits of using pre-filled syringes, including contamination prevention, compatibility within a sterile field, time savings, fewer mistakes, and reduced handling. Evidence suggests that a 4% sodium citrate solution is an effective choice for maintaining the patency of tunneled central venous catheters for dialysis. Jeroen's report highlighted the competitive advantages of CitraFlow in both the market and clinical practice.
Nasar Hussain, a leading distributor of medical devices to the NHS and private sector, discussed the commercial opportunities for CitraFlow from a distributor perspective. He emphasized that CitraFlow presents a unique opportunity for distributors to sell a product with the revenue potential of a pharmaceutical but regulated as a medical device. This product not only saves lives but also significantly reduces costs for healthcare providers.
Jane Gao, VP of R&D and RA, shared insights on regulatory engineering from a research and development perspective. “Amsino has obtained global approvals (FDA/CE/NMPA) in over 60 countries, and the current focus of the company's R&D is on tumor PICC lines for 10mL syringes.”
Looking ahead, CitraFlow has a wide range of application scenarios and substantial market potential. We eagerly anticipate its future developments.
At this time, CitraFlow is approved in the European, Chinese, and Canadian markets. Amsino is actively pursuing FDA clearance for the US market.
For all research references and sources, please see the CitraFlow Clinical Evidence Compendium. For more information or to contact a sales representative, submit the form fill here.
About Amsino International, Inc.
Established in 1993 and headquartered in the U.S., Amsino is a global medical device manufacturer with a mission to improve the safety and efficacy of patient care. The company operates multiple FDA-registered manufacturing, R&D, and distribution facilities in North America and Asia under the ISO13485 quality management system.
Q&A from the CitraFlow Seminar
- How does citrate reduce the biofilm in a catheter?
Trisodium citrate disrupts the biofilm matrix, making it difficult for bacteria to adhere to the catheter surfaces. This reduces the overall biofilm formation and helps in maintaining catheter patency. Considering possible mechanisms, it is likely that the most important effect of TSC is the chelation of the divalent cations Ca² and Mg². From dentistry research, it is known that a Ca²- and Mg²-chelating agent like TSC inhibits the growth and coaggregation of microorganisms and may prevent the formation of a biofilm that consists of microbes in a firm glycocalyx. - Is it a prevention of the biofilm inside the catheter?
Yeah, that is correct. In the UK, CitraFlow is widely used across most major cities. The key insight we’re gaining about antibiotics is this: the product works best when implemented from the moment a new catheter is placed. As we know, once bacteria adhere to the catheter wall, deposits like fibrin and other substances accumulate, creating a barrier that antibiotics struggle to penetrate. Therefore, early adoption of CitraFlow—starting at catheter insertion—delivers optimal results. - What is the shelf life of CitraFlow?
The shelf life is two years and a couple of months. - Is it possible to reduce the metallic taste? Do you have any recommendations?
As shown in our presentation, catheter lumens often have smaller internal volumes (e.g., 1.2 ml or 1.8 ml) than their labeled size. To ensure proper locking, we recommend adjusting the citrate volume during the next treatment, for example, reducing it by 0.1 ml (using 1.7 ml for a 1.8 ml lumen). This maintains efficacy while minimizing side effects like metallic taste (dysgeusia). This approach has two benefits:
-Precision: The reduced volume ensures the locking solution reaches the catheter tip without overfilling.
-Patient Communication: If transient side effects occur, reassure patients that they’ll subside quickly. If symptoms persist, reduce the installed volume by 0.1 ml. - Can you use CitraFlow regularly in PIVC (peripheral intravenous catheters)?
This adjustment is rarely necessary in practice, as most clinicians typically use heparin for such cases. However, when required, the 4% citrate solution can be effectively used for this purpose. - For use with PIVC lines— is CitraFlow better than NaCl for maintenance?
We know that hospitals are using it, but it's not very common. - The CitraFlow in the EU is certified as CE/MDD, but does it meet MDR, or is it still in transition?
CitraFlow is certified as CE/MDD with the extension until December 31, 2028. The MedXL/Amsino regulatory team is working hard to obtain the CE/MDR as soon as possible. - Can it be used in PICC lines?
Yes, we have successfully implemented citrate solutions for lines in response to clinical demand. During periods of supply constraints, we've maintained treatment continuity by optimizing our production capabilities. Our clinical experience shows superior outcomes with 4% citrate compared to heparin in line management. For these applications, we specifically developed a 10 mL syringe system, as smaller volumes cannot generate sufficient pressure for proper line clearance per clinical guidelines. We're currently collaborating with Royal Marsden Hospital—London's premier cancer center—to evaluate 30% citrate for high-risk oncology cases where infection prevention is critical. This research may lead to further development of even higher-concentration formulations for specialized applications. - Is CitraFlow 4% concentration enough for a hemodialysis catheter, or is it better to use CitraFlow 30%?
In our professional opinion, the 30% concentration offers distinct advantages due to its dual antimicrobial and anticoagulant effects compared to 4%. However, the optimal choice depends on each hospital's specific circumstances: (1) For facilities with strong catheter care protocols and already low infection rates, 4% citrate remains a solid choice. (2) In observed clinical practice, some dialysis centers alternate concentrations—using 4% for Monday/Wednesday treatments and 30% or 46.7% for Thursday/Friday sessions to provide extended protection over the weekend. (3) For maximum antimicrobial protection, I recommend 30% as the balanced choice, with 46.7% offering even greater efficacy in high-risk situations. Ultimately, this decision rests with the treating nephrologist based on individual patient needs and institutional infection control metrics. - Can we use UK hospitals as a reference for any chance of a marketing collaboration with a UK distributor in Malta?
We have extensive market understanding and proven experience in this field. Through our collaborations with Maltese healthcare providers, we've successfully addressed exit-site infection challenges with 100% reliability in our solutions. - Can they use you as a reference?
Yes, we can provide support. We will provide:
-Clinical guidelines from UK hospitals
-Complete chemical composition data
-Dosing recommendations tailored to your therapeutic goals
For all references and sources, visit the CitraFlow Clinical Evidence Compendium
