Hoag Hospital offers revolutionary device for treating intracranial aneurysms.

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--April 1, 1996--Hoag Memorial Hospital Presbyterian is now offering the Guglielmi Detachable Coil (GDC), a revolutionary medical device recently approved by the FDA for the treatment of high-risk or inoperable intracranial aneurysms.

The device is inserted into the aneurysm through a miniature catheter guided to the aneurysm through the body's arteries with help from X-ray visualization. Such an approach substitutes for conventional brain surgery which requires opening the skull and approaching the aneurysm typically found underneath the brain.

"This breakthrough technology offers hope to patients in whom conventional neurosurgery is life-threatening, or at least poses high risk of further neurological damage," said Dr. Michael Brant-Zawadzki, medical director of neuroradiology at Hoag Hospital.

"Prior to the GDC, little could be offered such patients other than supportive care. The complications of aneurysmal rupture often result in a high rate of rebleeding and death," Brant-Zawadzki added.

Intracranial aneurysms are thin balloon-like defects bulging from weakened arterial walls in the brain, and may cause pressure on adjacent neural structures as they enlarge. This can produce visual disturbance, dizziness and other signs.

If they rupture, such aneurysms produce a sudden stroke, and even death in one out of three patients initially, and an additional third of patients in the month following. Such a "blowout" of the aneurysm can be prevented either by traditional surgical approaches, or the new GDC coil procedure.

According to the National Stroke Association, stroke is our nation's third leading cause of death, resulting in 150,000 deaths every year. Stroke increases with age, with the risk doubling after age 55. For adults over age 65, the risk of dying from stroke is seven times that of the general population.

Nearly 40,000 people in the United States are diagnosed each year with intracranial aneurysms and approximately 25 percent of these -- because of the aneurysm's location, structure, or the patient's medical condition -- are deemed either completely inoperable or at very high risk for conventional surgical repair.

For these people, the GDC is the first FDA-approved medical device available to treat their condition non-surgically.

Here's how it works. The GDC coil is made of soft platinum alloy material, and looks much like a miniature "slinky." It is attached to a guide wire, both being positioned through a microcatheter inserted through a skin incision in the groin and threaded through the vasculature of the body into the cerebral artery harboring the aneurysm.

The tip of the catheter is placed in the aneurysm. The GDC coil is then pushed out through the microcatheter and positioned into the aneurysm site, and then its position checked.

If it is well-seated, a very low voltage electrical current detaches the coil from the guide wire inside the microcatheter. This leaves the GDC coil within the aneurysm, and with this technique the aneurysm is "packed" with multiple such coils.

This isolates the aneurysm from the circulation, thereby greatly reducing the likelihood of rupture and subsequent hemorrhagic stroke. The whole procedure takes anywhere from two to five hours, being much shorter than conventional surgery. Because the procedure does not require conventional surgical approach, there is generally no need for a long recovery from the procedure.

The coil is left in the patient permanently, and is periodically checked through follow-up X-rays.

"Clinical trials have shown that in those people who have suffered an aneurysmal bleed, the GDC dramatically reduces their chances of suffering a second rupture which has a high mortality rate as well as high disability rate in those who survive," Brant-Zawadzki explained.

"The GDC coil and its ability to treat intracranial aneurysms has added to the armamentarium of other anti-stroke approaches such as thrombolytic drugs and neuroprotective compounds used for other types of stroke. These new strategies are revolutionizing the medical care of patients with neurological diseases leading to stroke," Brant-Zawadzki added.

Hoag's GDC program was started following the FDA's approval of the device in September of 1995. The team consists of neurosurgeons, neurologists, neuroradiologists, nurses and technicians. Although several patients were treated prior to FDA approval on an experimental protocol basis, since the approval a larger number of patients have been treated with gratifying results.

"Although study of long-term outcomes awaits further analysis, the initial results have been extremely satisfactory," said Brant-Zawadzki. "Our collaboration with the team from the University of California at San Francisco, early pioneers in this technology, has been very fruitful and enabled us to gain early and ongoing experience with this treatment methodology.

"Hoag Hospital is the first hospital in Orange County to offer this procedure on a routine clinical basis," added Brant-Zawadzki.

The GDC coil also has applications outside of the brain, as it can be used for other types of malformations of the body's blood vessels. The procedure is routinely covered by insurance, particularly given its lower cost than conventional surgical approaches which require operating room time and technology.

In those patients treated prior to aneurysm rupture, the hospital stay can be as short as two days (as was the case in Hoag's most recent patient treated, a 74-year-old woman with progressive visual paralysis caused by a deep-seeded aneurysm unapproachable by surgical means).

For more information about Hoag's GDC program, call 714/760-5942.

Hoag Memorial Hospital Presbyterian is an acute-care non-profit hospital in Newport Beach. In addition to advanced programs in neurology, neurosurgery and orthopedics, Hoag Hospital has centers of excellence in heart, cancer and women's health services.

CONTACT: Hoag Memorial Hospital Presbyterian, Newport Beach

Maureen Mazzatenta, 714/574-6985