Food & Drug Law Weekly
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Cardiovascular Care
Untested catheter used in trials of recalled stent
September 24th, 2004
A catheter linked to three recalls of Boston Scientific stents had not been tested in a human clinical trial, according to U.S. Food and Drug Administration (FDA) records. The Boston Globe reported that Boston Scientific used one catheter when it ran clinical trials of its Taxus stent, but paired the stent with a different catheter when it went on the market after FDA approval. The FDA commonly allows clinical trials of one device to prove the safety of a similar one. Some devices can receive approval in as little as 90 days without clinical trials. The defect involves a balloon used to expand the metal-mesh stents into...
Source: Food & Drug Law Weekly (2004-09-24)
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