Micrus hopes to break into the underpenetrated market of minimally invasive treatments for cerebral aneurysms with a microcoil that has, it claims, performance characteristics that are superior to Target Therapeutics' Guglielmi Detachable Coil.
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UK investigators' recent decision to call an early halt to enrollment in a major study comparing neurosurgical clipping to endovascular coil treatment of ruptured cerebral aneurysms may signal a significant change of practice habits in a critical area of neurology. The findings, if they're as good as they appear to be, could do to surgical clipping and endovascular coils what the BENESTENT trials of the early 1990s did to promote stenting over balloon angioplasty in patients with coronary artery disease.
Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.