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Feds Pull Plug on Anti-Stroke Brain Stent as a Treatment Tool


Posted on Sep 14, 2011

Across the country in studies at University medical centers, doctors were using experimental brain stents to try and prevent strokes. A stent is a small mesh-like device placed into a vein or artery that is obstructed with plaque. They're designed to keep open the vein or artery.

These specific brain stents were designed to prevent narrowing of small vessels in the brain which can cause small strokes, known as TIA's or transient ischemic attacks.

According to Newsday, recent findings indicate there were a high number of strokes and deaths among patients who received this experimental stent.

Out of 451 patients in the experimental trial, half received the experimental device and half received medication. 15% of those suffered stroke within the first 30 days. Five died. Of the patients who instead received medicine, 5.8% of those on blood thinners and aspirin had a recurrent stroke and only one died.

The stent, developed by Boston Scientific was apparently approved by the Feds as a humanitarian exemption for people who experience a stroke and failed drug therapy. A drug exemption is based on hopeful but limited data that does not require the drug company to provide extended research on patients who have actually used it.
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What does this mean if you suffered stroke or your loved one died as a result of this experimental stent? Does that mean you might have a valid claim against the drug manufacturer?

You might, but there many unknowns that need to be explored. For example, what type of risks were you told about? Was it explained to you that this was an experimental study fraught with risks and a limited database of patients who had tested the device?

To learn more about how these types of cases were, I encourage you to explore my educational website. If you have legal questions about your particular matter, pick up the phone and call me at 516-487-8207 or by e-mail at lawmed10@yahoo.com. I welcome your call.

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Gerry practices law exclusively in the State of New York. Within New York he practices primarily in the following counties: New York, Brooklyn, Queens, Bronx, Staten Island, Nassau and Suffolk. Technically, Brooklyn is known as "Kings County," and Manhattan and New York City are known as "New York County." Staten Island is known as "Richmond County." These counties make up the New York metropolitan area.