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CINN treats first patient with breakthrough stent for aneurysms

Posted on June 19, 2007

Chicago – June 19, 2007 – Endovasular neurosurgeon Demetrius Lopes, MD and Neuroradiologist Thomas Grobelny of the CINN at the Neurologic & Orthopedic Hospital of Chicago introduced another breakthrough procedure for patients with aneurysms. Today, they treat the first patient in Illinois with the Cordis Enterprise Vascular Reconstruction Device and Delivery System.

An intracranial aneurysm is a weakness in the wall of a blood vessel in the brain that balloons out, forming a thin-walled bubble or sac. Approximately 30,000 intracranial aneurysms present annually. Some 15,000 patients are treated and up to 4,000 of these individuals are likely to need vascular reconstruction.

Today, many of these patients in most centers require open surgery-clipping an aneurysm requires opening the skull under general anesthesia, a three to four-day hospital stay and carries up to an approximate 12 percent probability of mortality/morbidity for patients.

Another treatment which may be available to patients in select institutions is a less invasive neurovascular intervention. Most patients who undergo an elective neurovascular procedure stay in the hospital one or two days and recover fully after about a week.

Through a neuroendovascular intervention, Lopes and Grobelny will place the first Enterprise Vascular Reconstruction device in a 58-year-old female who was diagnosed with an aneurysm during an exam to treat her balance disturbance and tinnitus, or ringing in the ears.

With this procedure, they will fill the aneurysm with coils to help ensure blood from the vessel does not continue to fill up the sac. Some aneurysms, in particular wide-neck aneurysms, can be difficult to treat with coils alone. Because of this, doctors and researchers began using stents that act as a scaffold to reconstruct the blood vessel and support maintenance of the coils inside the aneurysm. The Enterprise system is a significant advance in this technology because it has a closed-cell, versus open cell, design that better ensures coils will not herniate through the stent and into the parent blood vessel. They will place the device over the neck of the aneurysm to keep the coils packed in, effectively remodeling the blood vessel, shutting off the aneurysm from blood flow and restoring more normal blood flow through the parent blood vessel.

According to Lopes, the introduction of the Enterprise stent is significant because it allows endovascular neurosurgeons to treat a larger number of aneurysms in a minimally invasive way that is not as risky as surgery. And, closing off these aneurysm is an effective way to prevent hemorrhagic stroke, which occurs when a cerebral aneurysm bursts and bleeds into brain tissue. In the U.S., stroke is the third leading cause of death, behind heart disease and cancer. Each year, about 700,000 people suffer a stroke according to the American Heart Association.”In the past, we couldn’t recommend surgery for patients with an aneurysm who were symptom free because the surgery itself was risky,” he said. “But, this new remodeling procedure now allows us to use the body’s circulatory system to navigate the device into the area where the aneurysm is without performing an open craniotomy.”

The clinical outcomes from the Cordis Enterprise Vascular Reconstruction Device Study, involving patients in Europe and the U.S., were assessed by an independent core lab, establishing a new standard for clinical evidence in the treatment of intracranial aneurysms. Data from the independently evaluated clinical study suggest that the device is a promising assist device for the treatment of aneurysms, however, the effectiveness of the device for this use has not been demonstrated.

The Food and Drug Administration has granted Cordis, Inc. a Humanitarian Device Exemption and the company is working with top doctors, like Dr. Lopes and Grobelny, to carry out this promising approach to treating patients with aneurysms. In fact, Dr. Lopes and Grobelny are considered the foremost expert team in the world in treating complex aneurysms.

HDEs are granted when a medical device is used to treat a disease that affects fewer than 4000 patients annually. In an effort to provide treatment for these types of conditions, humanitarian use devices are exempt from the efficacy requirements of devices intended to treat more common conditions.