Tuesday, April 19, 2011

News Briefs: FDA Approves Non-Surgical Aneurism Treatment

David Gennert

The FDA has given “Premarket Approval” to the Pipeline Embolism Device, manufactured by ev3 of Menlo Park, California, for the treatment of brain aneurisms without the necessity of open surgery.

Aneurisms are bulges that develop in blood vessels due to blood pressure pushing against a weakened portion of a vessel. Aneurisms in the brain are particularly common, with one of the more frequent locations being at the base of the brain in the internal carotid artery, which is the one of the main blood suppliers of the brain. If left untreated, aneurism can bulge enough to impinge upon surrounding brain tissue, causing neurological symptoms, or they can rupture, causing a life-threatening hemorrhage.

The device is a metal mesh tube that is inserted through a blood vessel in a patient’s leg into the carotid artery near the site of the aneurism. Once in place, the device is expanded against the neck of the aneurism, which limits blood flow to the aneurism. This lack of blood flow causes blood left in the aneurism to clot and the aneurism to shrink over time, both of which help reduce the risk of a ruptured aneurism. Past methods of treating brain aneurisms mostly included surgical procedures, which had the potential of causing serious complications, such as damaging surrounding brain tissue, disease recurrence, and stroke.

According to the clinical studies, 70% of aneurisms treated remained blocked by the device without significant narrowing of the artery at that location after one year following the insertion procedure.

The device has been approved in Europe and has been on the market outside the US since July of 2009. According to the parent company of ev3, Covidien, it will become available at existing clinical sites in the US shortly.

Petrochko, Cole. “FDA Okays Aneurysm Device.” Medpage Today. 10 April 2011. 15 April 2011.
Zacks Equity Research. “Covidien's Pipeline Device Cleared.” Zacks Investment Research. 7 April 2011. 15 April 2011.
Roberts, Scott. “Device Approved to Treat Brain Aneurysm.” Bloomberg Business Week. 14 April 2011. 16 April 2011.
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