Endovascular Aortic Repair Devices approved by the FDA Following Testing at UNC

Two endovascular aortic repair devices tested in clinical trials at the University of North Carolina School of Medicine have been approved by the U.S. Food and Drug Administration (FDA) for use in the United States.

Endovascular Aortic Repair Devices approved by the FDA Following Testing at UNC click to enlarge Mark Farber, MD

Contact: Laura Melega, UNC Center for Heart and Vascular Care
Laura_melega@med.unc.edu, (919) 843-8217

Thursday, Sept. 27, 2012

CHAPEL HILL, N.C. -- Two endovascular aortic repair devices tested in clinical trials at the University of North Carolina School of Medicine have been approved by the U.S. Food and Drug Administration (FDA) for use in the United States.

Mark Farber, MD, Director, UNC Aortic Disease Management and Associate Professor of Surgery and Radiology in the UNC School of Medicine, served as the national principal investigator for both clinical trials.

Endovascular repair of aortic injury or disease involves the aorta, which is the human body’s main artery and provides oxygen-rich blood from the heart to the rest of the body. Aortic disease or injury can stretch, weaken, or damage the aorta, and if left untreated, can be fatal.

In an endovascular repair, the physician makes small incisions in the patient’s groin, through which catheters will be threaded into the patient’s blood vessels.  Through these incisions, the aortic repair device is guided to the point of the disease or injury, then fastened in place to reinforce the aorta.  Endovascular procedures typically require a 1-2 day hospital stay, compared to a week or longer for an open repair.

The RELAY ® Thoracic Stent Graft with PLUS Delivery System

The RELAY device is specifically designed to treat thoracic aortic aneurysms, which occur in the aorta as it passes through the chest.  Each year, more than 15,000 people in the United States are diagnosed with a thoracic aortic aneurysm, making it the 13th leading cause of death in the country.

The RELAY device offers a wide range of sizes and ease of use to help to expand the use of this minimally-invasive treatment to a broader segment of patients. It is manufactured by Bolton Medical.

The U.S. study included more than 120 endovascular patients at 30 hospitals across the country.

Dr. Farber states, “The RELAY Thoracic Stent Graft allows for precision and conformability, especially in patients with more challenging anatomies. As a physician, I find that the RELAY device makes it easier for me to offer this life-saving treatment to a broader population of patients suffering from thoracic aortic aneurysm.”

The Conformable TAG® Thoracic Endoprosthesis

The TAG device is used for endovascular repair of a traumatic thoracic aortic transection.  A transection is a tear in the wall of the aorta.  Over 8,000 people each year experience a transection of their aorta, involving profuse bleeding and high mortality rate. It is most often caused by a severe injury to the chest as a result of a motor vehicle accident, crushing of the chest, or a high fall.  

Prior to the successful clinical trial led by Dr. Farber, the only treatment option for traumatic thoracic aortic transection was open surgical repair.  This minimally-invasive endovascular repair of traumatic thoracic aortic transection reduces recovery time and pain for patients who have experienced this type of transection.

As the national principal investigator for the TAG® trial, Farber says, “We gained a great deal of insight and knowledge from the traumatic transection trial…Through the research, we were able to illustrate the TAG device’s capabilities and help to demonstrate that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative to open surgical repair.”

It is manufactured by Gore® Medical.

With these newly-approved devices, patients experiencing aortic disease or injury have more life-saving options available.   At UNC, 99 percent of all aortic patients receive their devices through this minimally-invasive endoscopic surgery.  

About UNC Aortic Disease Management
Aortic Disease Management is part of the UNC Center for Heart and Vascular Care.  It is one of the leading centers in the United States, and one of only a few centers in the entire country to offer comprehensive minimally invasive treatment of complex aortic disease.  Aortic Disease Management leads the way in conducting clinical trials for the advancement of leading-edge aortic treatments. As a result of that commitment to developing new procedures and treatments, greater than 95% of patients with aortic problems at UNC who require procedures can now be treated with minimally invasive techniques.  

For the convenience of our referring physicians and their staff, the UNC Center for Heart and Vascular Care Open Access physician referral service facilitates consultation and collaboration with our team of Heart and Vascular physicians, coordinates all admissions and transfers through a single phone call, and guarantees immediate acceptance for patients. Contact Open Access at 866-862-4327.

Related links

Mark Farber, MD, Director, UNC Aortic Disease Management and Associate Professor of Surgery and Radiology, UNC School of Medicine – Photo and Biography

RELAY ® Thoracic Stent Graft with PLUS Delivery System – Device Animation and Photos

RELAY ® Thoracic Stent Graft with PLUS Delivery System – Bolton Medical media release

Conformable TAG Thoracic Endoprosthesis – GORE Medical media release

Conformable TAG Thoracic Endoprosthesis – FDA media release


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