Trial is the first to be initiated in FDA pilot program for U.S.-based first-in-human trials
Carolinas HealthCare System’s Sanger Heart & Vascular Institute became the first in the world to implant a branched stent graft specifically designed for branch vessel repair of thoracic aortic aneurysms on Thursday. This is the first arch graft available in a clinical trial and both the device and surgical approach are novel.
“This is an important milestone for Carolinas HealthCare System as well as the U.S. medical community.”
--Paul Colavita, MD, President of Carolinas HealthCare System’s Sanger Heart & Vascular Institute.
Additionally, this trial is one of nine chosen by the Food and Drug Administration (FDA) for a pilot program to encourage and facilitate early feasibility studies of innovative medical devices for first-in-human trials in the United States. Carolinas HealthCare System is the first site to perform a surgery as part of the pilot program. The branched stent graft is being investigated at two locations: Carolinas HealthCare System’s Sanger Heart & Vascular Institute and the Cleveland Clinic, which is scheduled to begin implanting the device soon.
“This is an important milestone for Carolinas HealthCare System as well as the U.S. medical community,” said Paul Colavita, MD, President of the Carolinas HealthCare System’s Sanger Heart & Vascular Institute. “Typically these studies occur outside the United States but the FDA has recognized a need to keep important medical trials and technologies in the country. We are excited to be a part of this program to help lead medical innovations in the U.S., as well as helping to lead the advancement of cardiovascular care through the trial and development of this new device.”
Thursday’s surgery was led by Carolinas HealthCare System’s Frank Arko, MD, who also led the design team for the branched stent graft. The branched stent graft design is based on an FDA-approved stent and could fill the need for repairing thoracic aortic aneurysms (TAAs) in patients whose aneurysms are inaccessible by traditional surgical methods. The device is designed to repair TAAs encroaching on the left subclavian artery (LSA).
The LSA is one of the main arteries that branches off from the aortic arch and supplies blood to the left arm and part of the brain. TAAs are dangerous bulges in the aorta near where the aorta originates at the heart. Left untreated, TAAs can rupture creating an extremely dangerous situation in which extensive bleeding usually leads to death.
“This endovascular treatment for aortic aneurysms provides an important alternative to open-chest operations,” Arko said. “By eliminating the need for invasive surgeries we should be able to reduce certain complications and hopefully improve outcomes for patients facing a life-threatening illness. This is a true accomplishment for our team and Carolinas HealthCare System.”
The stent is implanted with two catheters. One enters through the femoral artery in the leg and implants the device in the aorta near the LSA. The second catheter enters from the brachial artery in the left arm and snares the branch of the device and guides into the LSA. This catheter based approach is less invasive than thoracic surgical options, which can include multi-graft bypasses of the LSA. It is hoped that this device and approach will lead to fewer complications such as clots and spinal ischemia as well as shorter hospital stays and better outcomes for patients.
According to the Society for Vascular Surgeons, an estimated 40 percent of patients with descending thoracic aneurysms are not candidates for endovascular repair and this approach could apply to those patients. Approximately 45,000 people die from aortic diseases every year in the United States and up to 25 percent of aortic aneurysms are thoracic. Aneurysms along the aortic arch are the most complex to treat because of the key arteries that branch off from the aortic arch. TAAs are the most lethal type of aortic aneurysms – as many as one out of every five people die within five years if TAA is left untreated.