FDA Clearance Of World's First Catheter With Subcutaneous Securement System, Interrad Medical

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Oct 2008 - 4:00 PDT

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

Interrad Medical has developed a completely new and innovative method for catheter securement called SecurAcath. The SecurAcath System utilizes a small anchor that deploys in the subcutaneous tissue just beneath the skin to hold an indwelling catheter securely in place. There are over 12 million 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 System offers significant advantages over current securement methods. The SecurAcath system is designed to improve catheter securement by decreasing catheter maintenance time and related costs, reducing catheter-related infections by improving cleaning of catheter exit site and minimizing catheter motion, decreasing skin surface issues, and eliminating needle stick injuries that may occur when suturing catheters.

Joe Goldberger, Interrad's President and CEO commented, "The first placements of the SecurAcath PICC will begin shortly followed by worldwide commercialization."

The SecurAcath System has the potential to become the next standard of care for catheter securement. The Company is currently developing a stand-alone SecurAcath device that can be used with virtually any indwelling catheter. The stand-alone SecurAcath is being designed to work with all PICC, CVC, dialysis and drainage catheters.

About Interrad Medical, Inc.

Plymouth, MN based Interrad Medical, Inc. is a developer, manufacturer and marketer of medical devices, designed for minimally-invasive interventional and surgical procedures. The Company was founded by a group of physicians lead by practicing Interventional Radiologist and Interrad Medical Chairman, Michael Rosenberg, M.D. For more information, visit http://www.interradmedical.com.

This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with litigation, clinical trials, the regulatory approval process, reimbursement policies and commercialization of new technologies.