FDA Clearance for Additional Sizes of the SecurAcath Device

Officials from Interrad Medical Inc. a privately held medical device company, announce that it has received FDA clearance for four new sizes of the SecurAcath subcutaneous catheter securement device. In response to requests from clinicians throughout the United States, Canada, and Europe, the SecurAcath is now available to secure 3, 4, 5, 6, 7, 8 French size intravenous catheters.

There are more than 500 million intravenous access catheters placed each year worldwide. Currently, vascular access catheters secure on the surface of a patient's skin using sutures or adhesive devices. The SecurAcath is the only catheter securement device that does not require sutures or adhesives, enabling fast, safe, and continuous securement. The unique design of the SecurAcath secures and stabilizes catheters right at the insertion site using a small, blunt anchor that deploys and holds virtually painlessly in the subcutaneous tissue just beneath the skin. The device takes only seconds to place and seconds to remove, and secures for the life of the catheter. The SecurAcath is also designed to prevent catheter migration and pistoning, and allows for 360 degree site cleaning while secured.

The SecurAcath offers significant advantages over current securement and stabilization 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 is sutureless, therefore, it eliminates the potential for needlestick injuries that can occur when suturing catheters.

Joe Goldberger, Interrad's president and CEO comments, "Expanding from two to six sizes allows clinicians to use the SecurAcath on a wider range of catheters to meet their patients' needs, and allows broader use throughout the hospital."

The SecurAcath device is currently available in the United States, Canada, and parts of Europe, in 3F to 8F sizes for use with intravenous catheters. The company plans to expand indications and catheter platforms the SecurAcath works on in the coming months. Ultimately, the SecurAcath has the potential to become the next standard of care for catheter securement.