Interrad Medical, Inc. a privately held medical device company, announced today the publication of clinical study data for the SecurAcath catheter securement device in the Journal of Infusion Nursing, May/June 2013 issue and the Canadian Journal of Anesthesia May 2013 issue.
The paper in the Journal of Infusion Nursing is titled: A Prospective Postmarket Study to Evaluate the Safety and Efficacy of a New Peripherally Inserted Central Catheter Stabilization System. The paper provides the results of a clinical study that was performed to evaluate the safety and effectiveness of the SecurAcath device in preventing catheter dislodgement. The prospective study was conducted at three centers in the U.S. and enrolled 68 patients who had PICC lines secured with the SecurAcath device. The SecurAcath performed very well in the study. Some of the data highlights are: Low dislodgement rate of 1.5% (0.7/1,000 catheter days), low pain score of 0.7 on 0 to 10 scale, and low unplanned removal rate of 2.9%. 91.2% of patients had no securement-related device malfunctions or device related complications. The conclusion of the study is that the SecurAcath represents a novel, safe and effective method for catheter securement.
The publication in the Canadian Journal of Anesthesia is titled: A Prospective Trial on a New Sutureless Securement Device for Central Venous Catheters. The paper covers data from 74 patients who had CVCs secured with the SecurAcath device at two centers in Canada. Data highlights from this study are: Successful securement was achieved in 72 (97%) of cases. 2 cases of catheter dislodgement were attributed to improper coupling of the two device components; Interrad Medical has modified the device accordingly. 14 of 15 patients with previous CVC considered SecurAcath to be as or more comfortable than a sutured catheter. The paper also notes that multiple medical societies advocate sutureless securement devices in order to reduce the risk of infection. It is believed skin disruption near the catheter entry site is associated with increased risk of infection. Furthermore, avoidance of suturing is consistent with prevention of needlestick injury. The paper concludes that the SecurAcath provided safe and reliable securement of the CVC.
Gail Egan, MS, ANP, a principal investigator in the study stated, “The SecurAcath study data highlights a major clinical benefit of the device which is a very low catheter dislodgement rate. Reducing unplanned catheter replacement is better for patients because it promotes vein preservation and also creates a cost savings by lowering the total cost of care.” The Company also announces it will be exhibiting at two upcoming major meetings. The first is the Infusion Nurses Society (INS), May 20-22 in Charlotte, NC. The INS has over 7,000 members who focus on infusion therapy in hospital and home care settings.
The second meeting is the National Teaching Institute and Critical Care Exposition (NTI), May 21-23 in Boston, MA. The NTI is the annual meeting of the American Association of Critical Care Nurses. 7,000 nurses are expected to attend the meeting.
At these meetings, the Company will be highlighting the significant advantages and cost savings the SecurAcath offers over current securement and stabilization methods. The SecurAcath has a low catheter dislodgement rate which will decrease catheter replacement costs. The SecurAcath increases efficiency by decreasing the time required to secure, maintain and remove catheters. The device design allows for improved catheter site cleaning and minimizes catheter movement which may reduce catheter-related infections. Finally, the SecurAcath is sutureless, therefore, it eliminates the potential for costly needle stick injuries that can occur when suturing catheters.
The SecurAcath device is currently available in 3F to 8F sizes and the Company plans to expand indications for use the coming months. Ultimately, the SecurAcath has the potential to become the next standard of care for catheter securement.
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 practicing Interventional Radiologist and Interrad Medical Chairman and Chief Medical Officer, Michael Rosenberg, M.D. For more information, visit www.securacath.com.