Access Vascular has announced US Food and Drug Administration (FDA) clearance of its HydroMID midline catheter.
A press release from the company states that HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters, is the second device in its planned portfolio to obtain clearance.
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. This can result in thrombus accumulation or catheter-related infections.
HydroMID is a 4 French, single-lumen, midline catheter with a maximum usable length of 20cm. The midline catheter is due to be made available over the next few weeks to gain clinical feedback on its usage.
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.
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 US$4.4 billion venous access market. The company’s first product—HydroPICC—was FDA-cleared last year and is currently rolling out commercially in the USA with the focus of obtaining real-world clinical data.
“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 am 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.”