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MedStar Health Research Institute was the first in the world to enroll a patient in this critical study of a device to improve complex aortic arch disease treatment.
Patients with complex aortic arch disease that extends into the proximal descending aorta face a daunting surgical future. In many cases, they need at least two major surgeries to repair the enlarged aorta to prevent life-threatening complications such as rupture or dissection (tear in the wall of the aorta).
MedStar Health Research Institute is the first institution in the world to enroll patients in a post-FDA-approval study of a new device—the Thoraflex Hybrid frozen elephant trunk (FET) device—that makes surgery to treat complex aortic arch disease safer and quicker.
Traditionally, surgical treatment for complex aortic arch disease involves two procedures:
- First, the aortic arch itself is replaced through an incision made in the front of the chest (sternotomy)
- Second, the remaining aortic disease is replaced from the left side of the chest with a large incision between the ribs (thoracotomy)
The FET device helps reduce the number and complexity of surgeries, saving patients time and pain. We are bringing it to more patients through the global clinical study at MedStar Health Research Institute and learning more about its benefits.
Studying a simplified treatment.
The FET device is made up of both an arch graft and a stent graft that can be implanted in a single open-heart procedure. The stent graft, or “frozen elephant trunk” portion of the device, is fixed in the descending aorta, locking the device to channel blood flow and bypassing damaged parts of the aorta.
The EXTEND post-approval study is enrolling 200 participants at research sites worldwide to study the safety and effectiveness of the FET device. The enrollment criteria are intentionally broad to increase access and learning opportunities about how different people respond.
Benefits of clinical trials for MedStar patients.
Clinical trials at MHRI benefit local patients in many ways, including:
- Access to leading treatments and technologies throughout the MedStar Health system.
- New technologies and less invasive procedures to reduce complications and recovery time.
- Identification of improvement areas, which can significantly improve patient outcomes.
