Access Vascular, Inc., a company focused on developing advanced vascular access devices, has received clearance from the U.S. Food and Drug Administration for a new indication on its single-lumen MIMIX HydroMid and both single- and dual-lumen HydroPICC catheter lines. The FDA has approved updated labeling that recognizes these catheters as being made from a proprietary hydrogel material with anti-thrombogenic properties, meaning the design helps reduce the risk of blood clot formation on the catheter surface.
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James Biggins, CEO of Access Vascular, stated that this latest clearance marks an important step forward in vascular access care. He explained that through the use of their unique MIMIX Technology, these catheters can minimize thrombus buildup without the need for drug-based coatings. Biggins emphasized that AVI’s goal has always been to provide clinicians with tools that improve safety and effectiveness while delivering a better overall experience for patients.
The MIMIX material is a specialized hydrogel that forms a molecular barrier across the catheter’s outer and inner surfaces. Laboratory studies have shown that this structure helps reduce blood clot accumulation and blockage in catheter pathways. However, it is important to note that human clinical studies have not yet confirmed the clinical effects, and these catheters are not intended to treat patients who already have vein thrombosis.
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What makes these devices stand out in the market is that they are currently the only peripherally inserted central catheters (PICCs) and midline catheters (MIDs) cleared by the FDA as anti-thrombogenic without the use of drugs. Since the technology works without drug elution, it eliminates potential complications related to medication-based coatings, such as allergic responses or heparin-induced clotting issues.
AVI continues to focus on creating safe and reliable solutions that improve how healthcare providers manage vascular access, aiming to support better patient outcomes across hospitals, outpatient clinics, and healthcare systems globally.
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Source- businesswire
