A new technology called the Pipeline embolization device (PED) shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, reports the December issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
Data collected since the PED was approved for marketing show generally good results in "real world" clinical practice. However, the report raises concerns about fatal bleeding and other serious complications, especially for aneurysms in one specific location. The lead author of the study was Dr. Peter Kan of University at Buffalo, N.Y.
Pipeline Device Shows Promising Results…
The researchers evaluated "early postmarket" results—that is, after approval by the U.S. Food and Drug Administration (FDA)—using the PED at seven surgical centers. The PED is designed for use in treating certain types of aneurysms that can't be blocked off by surgery or other treatments, such as "wide-necked" or giant aneurysms.
An aneurysm is a weakened spot in a blood vessel wall. If the aneurysm enlarges or ruptures (breaks), it can cause a stroke or life-threatening bleeding in the brain. The study reflects the increased emphasis on collecting postmarketing data on newly approved medical devices to see if the results in initial clinical experience are comparable to those in research trials. The PED received FDA approval for use in treating specific types of brain aneurysms in 2011.
The study included 62 PED procedures performed to treat aneurysms in 56 patients. The patients' average age was 59 years. More than 40 percent of the aneurysms were discovered incidentally, before they caused any symptoms or bleeding.
On average, it took two PEDs to treat each aneurysm. Some patients needed additional procedures related to problems deploying the PEDs. In one-fourth of aneurysms, additional "coil" treatments were used in addition to PEDs to help block off the aneurysm.
Three-month follow-up data were available for 19 patients. In 68 percent, the aneurysm was completely blocked off. Two patients had some narrowing within the Pipeline device—this was successfully treated with an additional angioplasty procedure.