BILLERICA, Mass. – Access Vascular, Inc. (AVI), a leader in advanced vascular access solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared a new indication for its single-lumen MIMIX HydroMid and single- and dual-lumen HydroPICC catheter lines. The updated labeling recognizes the company’s proprietary hydrogel material as having anti-thrombogenic properties designed to reduce the risk of thrombus formation on catheter surfaces.
“The MIMIX HydroMid and HydroPICC catheters represent a significant advancement in vascular access technology,” said James Biggins, Chief Executive Officer of Access Vascular. “By leveraging our proprietary MIMIX Technology, these devices help reduce thrombus accumulation without the use of drugs, reflecting our mission to support clinicians in delivering safer and more effective care for patients.”
MIMIX Technology uses a bulk hydrogel material that forms a molecular-level barrier on both the external surfaces and internal pathways of the catheter. In vitro studies have shown that this barrier helps reduce thrombus accumulation and occlusion. The clinical impact in human trials has not yet been evaluated, and the devices are not intended for the treatment of existing vein thrombosis.
The MIMIX HydroCatheters are the only FDA-cleared, drug-free peripherally inserted central catheters (PICCs) and midline catheters (MIDs) indicated as anti-thrombogenic. Because they are designed to achieve performance without drug elution, the AVI catheters avoid risks associated with drug coatings, such as allergic reactions or heparin-induced thrombocytopenia and thrombosis.
Access Vascular continues to advance innovative, safe, and effective vascular access solutions for hospitals, clinics, and healthcare providers worldwide.
