FDA grants Interrad 510(k) clearance for SecurAcath Universal Subcutaneous Catheter Securement System

Interrad Medical, Inc. a privately held medical device company, announced today that it has received FDA 510(k) clearance of its SecurAcath Universal™ Subcutaneous Catheter Securement System.

“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.”

The SecurAcath Universal System is a completely new method for catheter securement. The unique 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. The device is fast and easy to use, allows for catheter length adjustments, and does not need to be replaced. There are 15 million central venous access catheters placed each year worldwide. Currently, catheters are secured on the surface of a patient's skin using sutures or adhesive devices.

The SecurAcath Universal System offers significant advantages over current securement methods. The device can reduce costs by decreasing the time required to secure, maintain and remove catheters. The device design allows for improved catheter site cleaning and minimizes catheter motion which may reduce catheter-related infections. Finally, the SecurAcath Universal System is sutureless; therefore, it eliminates the potential for needlestick injuries that can occur when suturing catheters.

Recently, the Company also received both the CE mark and Health Canada clearance for the SecurAcath Universal System. Clinical placements are ongoing in Canada and the device is performing well.

An abstract of clinical data from the first-generation SecurAcath PICC device was presented at the World Congress on Vascular Access (WoCoVA) in Amsterdam by Gail Egan Sansivero, MS, ANP, a leading Nurse Practitioner in Interventional Radiology in Albany, New York. Gail stated, "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."

Joe Goldberger, Interrad's President and CEO commented, "The Company plans to begin global commercialization of the SecurAcath Universal immediately."

The device is currently available in 5F and 7F sizes and the Company plans to expand size availability in the coming months. Ultimately, the SecurAcath Universal System has the potential to become the next standard of care for catheter securement.