Interrad Medical, a privately held medical device company, has received FDA 510(k) clearance for its SecurAcath Universal Subcutaneous Catheter Securement System.
Interrad Medical claimed that the design of the SecurAcath Universal System secures catheters right at the insertion site using a small, blunt anchor that deploys in the subcutaneous tissue just beneath the skin.
Interrad Medical said that the device need not to be replaced and is fast and easy to use allowing catheter length adjustments. Currently, catheters are secured on the surface of a patient’s skin using sutures or adhesive devices.
The device design allows for improved catheter site cleaning and minimises catheter motion which may reduce catheter-related infections. Finally, the SecurAcath Universal System is sutureless and therefore, eliminates the potential for needlestick injuries that can occur when suturing catheters.
Recently, Interrad Medical had also received both the CE mark and Health Canada clearance for the SecurAcath Universal System. Clinical placements are ongoing in Canada and the performance of the device is found well.
The device is currently available in 5F and 7F sizes and Interrad Medical plans to expand size availability in the coming months.
Joe Goldberger, president and CEO of Interrad, said: “The company plans to begin global commercialization of the SecurAcath Universal immediately.”
Gail Egan Sansivero, nurse practitioner in interventional radiology in Albany, New York, said: “Based on our positive experience with the first-generation device, we are excited to begin using the SecurAcath Universal device as soon as it is available.”