Access Vascular Prepares Catheter Location Technology for FDA Submission

New Technology to Expand Access Vascular’s Reach Into the $520 million Peripherally Inserted Central Catheter (PICC) Market

BILLERICA, Mass.--(BUSINESS WIRE)--Access Vascular, Inc. (AVI), a medical device company dedicated to reducing and eliminating common and costly vascular access complications with its novel MIMIX® catheter material, announced today that it is preparing to submit its HydroGUIDE™ catheter placement technology for U.S. Food & Drug Administration (FDA) clearance.

Nearly two-thirds of the more than 2.7 million PICCs placed each year are guided by catheter locating technology, allowing the devices to be placed at the bedside by skilled nursing staff. Although AVI catheters are compatible with many catheter placement systems, the addition of AVI’s HydroGUIDE™ technology to the AVI product lineup reinforces its commitment to advancing vascular access and paves the way for future portfolio additions. HydroGUIDE™ will allow nurses to combine the benefits of AVI’s award-winning MIMIX® catheters with the ability to determine appropriate catheter placement – without leaving the patient’s room.

HydroGUIDE is designed to fit seamlessly into existing clinical workflows with minimal capital expense, while offering the convenience of a highly mobile solution. Its patient-centric design prioritizes accuracy and ease of use, enabling real-time information to guide clinicians in making precise adjustments during catheter placement.

“Combining the innovative HydroGUIDE™ catheter tip location technology with AVI’s platform of MIMIX® vascular access devices creates a value-based solution for PICC line placement that ultimately may reduce complications and improve patient care,” said Lee Steere, Manager of IV Therapy Services for Hartford Hospital. “Access Vascular is positioned to make a significant difference in outcomes for vascular access patients.”

AVI’s proprietary MIMIX® technology imitates the body’s natural chemistry to evade the foreign body response and its associated complications. Data from multiple studies of catheters made using MIMIX® (the HydroPICC®, HydroPICC® Dual, and HydroMID® devices) has demonstrated significantly lower rates of complications associated with vascular access devices – with the potential for significant hospital savings and an improved patient experience.

AVI's FDA-cleared devices have been shown to lower complication rates by a factor of six, compared with standard catheters, and an in vitro study demonstrated a 99.99% reduction in bacterial adhesion.^1,2 For patients, this could mean fewer infections, less time in the hospital, and reduced risk of long-term health issues.

About Access Vascular

Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material. Engineered to mimic the body’s natural chemistry, Access Vascular’s MIMIX®-based catheters are designed to evade the foreign body response and complications that come with it. Our award-winning, FDA-cleared products are HydroPICC® and HydroMID®. For more information, please visit our website, and follow us on LinkedIn.

¹ Bunch J. A retrospective assessment of peripheral midline failures focusing on catheter composition. J InfusNurs. Sept/Oct 2022; 45(5):270-27. doi: 10.1097/NAN.0000000000000484
² LeRoy, K. J. 2023 Association for Vascular Access Scientific Meeting: Poster Abstracts. Journal of the Association for Vascular Access 1 May 2024; 29 (2): 51–66. doi: https://doi.org/10.2309/1557-1289-29.2.51