STANFORD, Calif.–(BUSINESS WIRE)–If Barbara Maluos
brain aneurysm had been discovered a few months ago, she would have had few
viable treatment options. She was one of the 10 to 15 percent of brain aneurysm
patients diagnosed each year with aneurysms so large and wide that they cannot
be reliably treated using conventional methods of treatment.
Fortunately, time was on Maluos side. The discovery of a
bulge in her carotid artery came after the Food and Drug Administration
fast-tracked approval of a brand-new intracranial device called the Pipeline
stent. This week, Stanford Hospital became the first hospital in Northern
California-and one of only two in the state-qualified to offer the Pipeline
treatment without restrictions. Maluo was one of Stanfords first Pipeline
The FDA has limited the Pipeline for use on aneurysms in the
internal carotid artery, the major blood vessel supplying blood to the front of
the brain. “We know that the device is safe in certain anatomy, like the
carotid,” said Michael Marks, MD, chief of Stanfords Interventional Neuroradiology Department. “The carotid is
also one of the most common sites for these large aneurysms to occur. As we
learn more, there may be additional applications for a device like this. But
our focus right now is treating those patients that weve had no good treatment
Maluo was first diagnosed with the aneurysm after going to a
hospital in Hilo, Hawaii. She had reacted badly to some pain
medication and was so “loopy,” she said, that doctors did a quick brain scan on
her. Thats when they discovered the large bulge in her carotid artery. Maluos
doctor sent her angiogram images by iPhone to Marks, who examined them and
realized she would be good candidate for the Pipeline.
A few days later, Maluo was at Stanford Hospital,
ready for her procedure. Through a small incision in her groin, Marks threaded
in a catheter along a path through Maluos blood vessels to help carry the Pipeline
to her brain.
Aneurysms occur when blood vessel walls weaken, causing them
to balloon out. People may walk around with brain aneurysms for years without
symptoms. The threat is that they will burst; the bleeding that follows can be
lethal. An estimated 6 million people in the United States (about one in 50)
have a brain aneurysm. Some 25,000 to 30,000 people every year experience
hemorrhages from a burst aneurysm; about 40 percent do not survive.
Some aneurysms are small and can be treated either by
filling them up with coils inserted through a catheter in a minimally invasive
procedure, or through neurosurgery that opens the skull, clamping them off with
clips. Some smaller aneurysms with wider necks can also be treated with
coils and stents developed especially to keep the coils from falling into the
Others, like Maluos, are so big and wide that coils and
standard stents are not adequate. In such cases, these traditional procedures
carry a higher risk and have a lower chance of success.
At first glance, the Pipeline looks like a standard
intracranial stent used with coils, but its distinctive design eliminates the
need for coils, which are used to fill a brain aneurysm to block blood flow.
The Pipelines netting is braided, with 48 strands interlocked into a dense
weave. Introduced into the artery through a microcatheter less than 0.027
inches in diameter, the Pipeline is placed to precisely expand and cover over
the neck or opening of the aneurysm. Its braided walls diminish the flow of
blood into the aneurysm, sealing it off while still allowing blood to flow
freely through the healthy part of the artery.
The blood in the aneurysm clots, blocking the aneurysms
ability to expand or rupture. The Pipeline allows all the blood vessels in
the area to remain functional. “You really dont want to sacrifice a major
blood vessel,” Marks said.
The new device was originally developed by a Menlo
Park-based company, and its clinical success won FDA approval after just a
years use in Europe. “It was a very fast
turnaround,” Marks said. “This stent was recognized as a treatment for a group
of patients who did not have any good treatment options.”
Maluo was out of the hospital quickly. “Its kind of amazing
to know that they were in there working on your brain and youre out in two
days,” she said. “I am just overjoyed to get it treated so quickly.” She has
since returned to Hawaii,
her life-threatening aneurysm safely sidelined.
About Stanford Hospital & Clinics
Stanford Hospital & Clinics is known worldwide for advanced treatment of
complex disorders in areas such as cardiovascular care, cancer treatment,
neurosciences, surgery, and organ transplants. It is currently ranked No. 17 on
the U.S. News & World Reports “America’s Best Hospitals” list
and No. 1 in the San Jose Metropolitan area. Stanford Hospital & Clinics is
internationally recognized for translating medical breakthroughs into the care
of patients. The Stanford University Medical Center is comprised of three world
renowned institutions: Stanford Hospital & Clinics, the Stanford University School of Medicine, the oldest medical
school in the Western United States, and Lucile Packard Children’s Hospital, an adjacent pediatric
teaching hospital providing general acute and tertiary care. For more
information, visit http://stanfordhospital.org/.