Ricardo Hanel, MD, PhD, neurosurgeon and director of Baptist Stroke & Cerebrovascular Center, is the first physician in the U.S. to use Cerus Endovascular's Contour Neurovascular System™ to treat a patient's brain aneurysm as part of a new study. With its first use in an American patient, the new device officially began its trial for submission for U.S. Food and Drug Administration (FDA) approval for widespread use in the U.S.
The Contour Neurovascular System for Intracranial Aneurysm Repair (NECC) is intended to help treat brain aneurysms that occur at the branching, or bifurcating, points of arteries in the brain. The device patches the opening of the aneurysm (neck) from blood vessels that supply the blood to an aneurysm that is bleeding or in danger of rupturing. A ruptured brain aneurysm can be a life-threatening condition.
In general, previous devices have brought an improved way to treat certain brain aneurysms; however, the current devices are shaped like a square. The Contour Neurovascular System is shaped like half of a football, and fits in some areas previous devices do not.
"We are pleased to be participating in this study and seeing how this tool performs," said Dr. Hanel. "The Contour device is likely to be a great addition to the toolbox for providing a minimally invasive, simple and safe way of treating brain aneurysms."
Eric Sauvageau, MD, neurosurgeon, and co-medical director of Baptist Stroke & Cerebrovascular Center, Amin Nima Aghaebrahim MD, interventional neurologist, and primary stroke director at Baptist Stroke & Cerebrovascular Center, and Dr. Hanel will participate in the NECC study by offering the Contour device as an option for patients over the next year.
Cerus Endovascular will then take the data gathered from Baptist and 19 other neurointervention centers to the FDA in a bid for approval.
"Given the real-world patient outcomes we have experienced in Europe, where the Contour Neurovascular System has had CE mark approved since March 2020, we are hopeful we will see similar, strong results from this trial," said Dr. Stephen Griffin, president of Cerus Endovascular.
Through clinical trials, Baptist Health provides its patients with the latest evidence-based treatments and preventive therapies, and leads the region in clinical trial participation. To learn more about treatments for brain aneurysms, strokes and other cerebrovascular conditions, visit Baptist Stroke & Cerebrovascular Center.
Click here for video, photos and more about the Contour Neurovascular System™