Until very recently I had not heard of a Pipeline Emblisation Device (PED) for intracranial aneurysms, probably because it is a very new procedure and not well known in Australia. According to available information, the PED is specifically for wide-neck aneurysms which are not easily treatable by other methods. While PEDs have been used in Europe since 2009, the USFDA only gave approval in the USA in April 2011. The FDA page gives very good information on the device and its intended use, however, it was still being called “new” in a December 2012 report in News Medical. EV3, an American company, provides an information booklet specifically on the PED which is excellent information for anyone diagnosed with a wide-necked aneurysm.
In Australia, while the PED procedure is being used, the Department of Health website notes it is still awaiting the draft DAP (Decision Analytical Protocol) from the “applicant”, whoever that may be. Certainly, that seems to be a lengthy process as evidenced by the Department of Health information on “Deadlines for a proposed decision analytical protocol”. Coviden, a US provider of the devices in Australia, only published final testing results in the US in June 2013, noting that “Investigators compared the Pipeline device to historical controls because no other blood flow diverting devices are available in the U.S. Effectiveness of stents has not been proven to FDA standards; and outcomes for surgical or other endovascular treatments have been suboptimal.” It is a little scary to read that in SA the Therapeutic Goods Administration (TGA) has issued a safety alert (although not a recall) for monitoring of aneurysms treated with PEDs in persons in aged care, a reminder that this procedure is still very new.
Overall, though, if you have a wide-necked aneurysm and are faced with the fact that traditional methods don’t historically work well with those, the PED is a light at the end of a rather bleak tunnel.
The US-based Brain Aneurysm Foundation has an exceptional booklet available on all aspects of aneurysms. In the absence of a similar resources in Australia, perhaps this booklet should be made freely available to every person in Australia who is diagnosed with a brain aneurysm, along with a list of Australian support resources, so others like me do not have to struggle to find the information which we so desperately need.