Ischemic stroke, according to the American Stroke Association, accounts for 87 percent of all stroke cases. It happens when there is a complete obstruction in a blood vessel supplying blood to the brain. When this happens a thrombus, better known as a blood clot, will form. The end result can be severe impairment and even death. A new device recently approved by the FDA has shown it is a far more effective treatment than the most commonly used clot remover.
The new device, pictured above, is called the SOLITAIRE Flow Restoration Device, and was approved by the FDA back in March 2012. The device works like a stent that penetrates the blood clot and then expands to contain the blockage, thus allowing for it to be removed and blood flow restored to the brain. Dr. Jeffrey L. Saver, director of the UCLA Stroke Center and a professor of neurology at the David Geffen School of Medicine at UCLA, led a study to prove the effectiveness of the SOLITAIRE device against the most commonly used device, the MERCI Retriever, which UCLA had helped develop years ago.
The results of the study were amazing. 61% of the patients who were treated with the SOLITAIRE device suffered no bleeding in or around the brain. The MERCI Retriever was only effective for 24%. Another strong positive for the SOLITAIRE device was seen in the mortality rate. Three months after the procedure there was 17.2% mortality rate with the SOLITAIRE device, compared with a 38.2% rate with the MERCI Retriever.
Below is a video that shows how the SOLITAIRE device works.
“This new device is significantly changing the way we can treat ischemic stroke,” said the study’s lead author, Dr. Jeffrey L. Saver. “We are going from our first generation of clot-removing procedures, which were only moderately good in reopening target arteries, to now having a highly effective tool.”
This device will be used when it is determined that clot busting drugs are not being effective for clot removal. There is a four and a half hour window after a stroke that has to be allowed before this type of treatment can be used. The time for treatment from beginning of stroke symptoms to the start of the clot-retriever treatment averaged 5.1 hours in the study. The study was actually stopped early due to the dramatic safety differences between the experimental device and the older one. “Nearly a decade ago, our UCLA Stroke Center team invented the first stroke retrieval device — the MERCI Retriever — and now we are pleased to have helped develop and successfully test a superior, next-generation clot removing device,” said Dr. Reza Jahan, associate professor of radiology at UCLA and the study’s principal neurointerventional investigator, who also led the pre-clinical studies. “It is exciting to have a highly effective new tool that can improve the outcomes for more stroke patients.”
This study was published in the journal The Lancet.