Adhezion Biomedical Receives FDA Clearance of Vascular Access Device Protection Technology

Adhezion Biomedical LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its SecurePortIVTM catheter securement adhesive, a highly versatile cyanoacrylate formulation which can be used with short-term or long-term vascular access devices to enhance device securement, seal the catheter insertion site, protect the patient from catheter related blood stream infection, and provide a water-resistant barrier—all in a single product.
 
SecurePortIVTM comes in a patented ergonomic applicator containing a proprietary cyanoacrylate formulation tailored specifically for use with vascular access devices. SecurePortIV is applied to the skin under the hub of vascular access devices and forms a film that holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. SecurePortIV is also applied over the catheter-skin insertion site forming a seal proven to immobilize surface bacteria and fungi, preventing them from entering into the catheter skin entry site while also providing a moisture-proof barrier. Additionally, SecurePortIV effectively seals the catheter insertion site which can help reduce the frequency of dressing changes. 
 
“SecurePortIVTM is the only cyanoacrylate adhesive in the world that has been cleared by the FDA for use with vascular access devices,” said Pete Molinaro, Adhezion’s CEO and chairman. “SecurePortIVTM has tremendous potential to greatly simplify the care and maintenance of vascular access devices while providing extraordinary value to healthcare facilities which can normally be achieved only through the combination of multiple different securement and catheter site management products.”
 
Adhezion Biomedical is privately held medical device company based in Wyomissing, Pa. Adhezion develops and manufactures medical cyanoacrylate products used in the treatment of wound closure, wound management, intravenous device securement and infection prevention.