FDA Clears HydroMID Midline Catheter From Access Vascular

Access Vascular Inc.’s HydroMID midline catheter has received U.S. Food and Drug Administration (FDA) clearance. Made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97 percent when compared to standard polyurethane catheters,¹ HydroMID is the second device in its planned portfolio to obtain regulatory clearance.

“FDA clearance for our second device demonstrates our commitment to a full product portfolio of venous access solutions and our commitment to help clinicians address the thrombus accumulation and catheter occlusion complications plaguing patients,” said Access Vascular CEO James Biggins. “I’m proud of our entire team for securing clearance. We look forward to working with clinicians to integrate our devices into their workflow and better understand the benefits that we can bring to patient treatment and care.”
 
Midline catheters have grown in popularity due to inclusion in the MAGIC (Michigan Appropriateness Guide to Intravenous Catheters) guidelines, and the elimination of the need for confirmatory chest X-rays for midline placement. Standard midlines are composed of polyurethanes or silicones, which may lead to protein adsorption.² This can result in thrombus accumulation³ or catheter-related infections.⁴
 
HydroMID is a 4 French, single lumen, midline catheter with a maximum usable length of 20 cm. HydroMID will be made available over the next few weeks to gain clinical feedback on the usage of this midline catheter.
 
The company’s expansion into midlines enables healthcare professionals to choose either a midline or peripherally inserted central catheter made of this novel, thrombus-resistant biomaterial, depending on their needs. Midlines, intended for use of up to 30 days, have the advantage of a generally higher level of patient comfort when compared to peripheral intravenous catheters (IVs) due to a fewer number of restarts.⁵
 
The release of the midline also furthers the company’s plans to develop a portfolio of thrombus-resistant venous catheters and devices composed of its proprietary biomaterial to address the $4.4 billion venous access market. The company’s first product – HydroPICC – was cleared by the FDA last year and is currently rolling out commercially in the United States with the focus of obtaining real world clinical data.
 
References
¹ Data on file. Reduction of thrombus accumulation evaluated using in vitro and in vivo models. Pre-clinical in vitro/in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation. Length difference between midline and PICC line does not impact result of testing.
² Andrade JD, Hlady V. Protein adsorption and materials biocompatibility: A tutorial review and suggested hypotheses. Berlin, Heidelberg: Springer Berlin Heidelberg; 1986. p. 1–63.
³ Anderson, James, et. al. Foreign body reaction to biomaterials; Semin Immunol. 2008 April;20(2):86–100
⁴ Seckold T, Walker S, Dwyer T. A comparison of silicone and polyurethane PICC lines and postinsertion complication rates: a systematic review. J. Vasc. Access. 2015;16(3):167-77.
⁵ Alexandrou E, et al. The use of midline catheters in the adult acute care setting – clinical implications and recommendations for practice; Journal of the Association for Vascular Access. 2011;16(1):35–41.