Pipeline embolization device gives new hope for treating complex
4 July 2011
Physicians at Rush University Medical Center are offering a
new and effective treatment to patients suffering from complex brain
The recently FDA-approved technology called the Pipeline
Embolization Device (PED) gives doctors the ability for the very
first time to treat some of the most complex and dangerous brain
aneurysms using minimally invasive techniques.
The treatment is focused on reconstruction or remodeling of the weak
blood vessel harboring the brain aneurysm.
“The Pipeline Device may offer improved patient results with a
safe and effective treatment of large or giant, wide-necked
aneurysms, which until now has been an unmet clinical need,” said Dr
Demetrius Lopes, neuroendovascular surgeon at Rush University
Medical Center. “We are able to help people who did not have a
better option and would otherwise die without treatment.”
Rush is one of only seven medical centers in the US with the
ability to offer treatment with PED and was one of only a handful of
centers in the US that participated in the initial FDA clinical
The premarket approval of PED is based on the results of the PUFS
(Pipeline for Uncoilable or Failed Aneurysms) clinical study, a
single-arm study of large and giant, wide-neck or fusiform aneurysms
that included safety and efficacy data on 108 patients.
It is estimated that one in 50 Americans have a brain aneurysm,
an abnormal ballooning of a portion of an artery in the brain due to
a weakened blood vessel wall.
“Treatment for aneurysms can be tricky, especially when they are
large or giant, wide-necked aneurysms,” said Lopes, who is an
assistant professor of neurological surgery at Rush University,
Large aneurysms, which are more than 10 mm in diameter and giant
aneurysms, which are more than 25 mm in diameter are especially
problematic. If left untreated, they can result in compression of
the brain and surrounding structures, bleed and cause ischemic
Previously, doctors would try filling an aneurysm with platinum
coils to block blood flow into the aneurysm and prevent rupture.
However, coiling, while effective for small aneurysms, would not
always work for large or giant aneurysms. The other option is to
open up the skull, and use a clip to clamp off blood flow to the
aneurysm if it is in a location where it can reached through open
brain surgery. This type of major surgery requires four to six weeks
The PED is a new class of embolization device designed to divert
blood flow away from the aneurysm. It is composed of multiple, fine,
individual strands of platinum and cobalt chromium which are braided
into a flexible, mesh tube. The device is threaded up through a
catheter placed in a blood vessel in the leg up to the brain. Once
the device is implanted across the neck of an aneurysm, the PED
essentially rebuilds the diseased brain artery by rerouting blood
flow away from the aneurysm and along the course of the normal,
reconstructed blood vessel.
“This novel technology is the only durable endovascular treatment
for large and giant brain aneurysms,” said Lopes. “It provides a
better chance of relief of brain compression, long-lasting aneurysm
occlusion and low complication rates.”
“Because reconstruction with PED is a minimally invasive
procedure where an artery in the leg is accessed through a tiny
incision, it is possible for patients to undergo treatment and leave
the hospital the very next day,” said Lopes.
The thinness of the device also allows for telescoping or
endovascular bypass, a technique where multiple PEDs are placed
within each other with less risk of narrowing the artery while
creating a new and stronger blood vessel.