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FDA Clears Access Vascular HydroMid® and HydroPICC® Catheters With Anti-Thrombogenic Indication

Access Vascular, Inc. (AVI), a leader in advanced vascular access solutions, today announced that the U.S. Food and Drug Administration (FDA) cleared a new indication for its single-lumen MIMIX® HydroMid® and single- and dual-lumen HydroPICC® catheter lines. The updated labeling recognizes the devices’ 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, CEO of AVI. “By leveraging our proprietary MIMIX® Technology, these devices help reduce thrombus accumulation without the use of drugs, reflecting our core mission of supporting clinicians in delivering safer and more effective care for patients.”

MIMIX® Technology is a bulk hydrogel material that creates a steric, molecular-level barrier on both the external surfaces and internal fluid pathways of the catheter. In vitro studies demonstrate that this barrier reduces thrombus accumulation and occlusion. Clinical impact in human trials has not yet been evaluated, and the devices are not intended for the treatment of existing vein thrombosis.

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 deliver performance without drug elution, the AVI catheters avoid the risks associated with drug coatings, including allergic reactions and/or heparin-induced thrombocytopenia/thrombosis.

AVI remains committed to developing safe, effective, and innovative solutions to enhance vascular access care for hospitals, clinics, and healthcare providers worldwide.

About Access Vascular, Inc.

Access Vascular, Inc., based in Billerica, Massachusetts, is a medical device company specializing in advanced vascular access solutions. The company develops and commercializes FDA-cleared products incorporating its proprietary MIMIX® Technology, designed to improve outcomes for healthcare providers and the patients they serve. For more information, visit www.accessvascularinc.com, or find us on LinkedIn.

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