Postmarketing Data Pours A Bit Of Cold Water Down Covidien’s Pipeline

In short

Covidien’s eV3 subsidiary business brought with it the Pipeline embolization device (PED) when it was acquired.  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.

Background

We’ve covered the Pipeline device before, most notably earlier in 2012 when UK’s National Institute for Health and Clinical Excellence (NICE) came out and supported use of the device in the NHS when it is used in patients with giant or complex intracranial aneurysms who would need large numbers of coils during stent-assisted coiling and who are unsuitable for neurosurgical treatment.

Data collected in the U.S. 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 researchers evaluated “early postmarket” results at seven surgical centres, including 62 PED procedures performed to treat aneurysms in 56 patients, 19 of whom were available for 3 month follow-up. In 68 percent, the aneurysm was completely blocked off, which is good. Two patients had some narrowing within the Pipeline device, which was successfully treated with an additional angioplasty procedure.

But the paper also includes some serious black marks including an 8.5 percent rate of major complications or death. Six patients had clots leading to strokes or transient ischemic attacks (“mini strokes”) after the PED procedure. Most of these patients had vertebrobasilar aneurysms—located in an area at the base of the brain where three major arteries meet.

In addition, four patients suffered bleeding, which developed up to two months after the PED procedure. Bleeding was fatal in all four cases, all of which lead the researchers to warned against any off-label use of the PED until more long-term data can be collected.

So the report concludes that this initial “real world” experience shows results similar to those achieved in clinical trials leading to FDA approval. It confirms that although treatment may take months to complete, the aneurysm is eventually completely occluded in most patients. Thus the PED offers an effective new option for patients with aneurysms that would previously have been difficult or impossible to treat.

Balancing the positive, the postmarketing data also show a significant risk of serious complications, including potentially fatal bleeding.

The researchers conclude, “Long-term data are needed to establish long-term efficacy and to understand the delayed complications of this new technology.”

Source: Eurekalert.org