January 23, 2008 Diagnostic Imaging. Penumbral Imaging Propels Trials Toward Wider Therapeutic Window More than a decade after the last FDA approval for a stroke drug, vampire bat saliva navigates process using updated techniques Jordana Bieze Foster -------------------------------------------------------------------------------- It's been a long, frustrating 12 years since an acute stroke drug last won over the FDA, a time in which the percentage of eligible patients actually helped by the drug has remained stuck in the single digits. All signs indicate, however, that the next acute stroke therapy to win approval will do so on the strength of a very different type of clinical trial, one that uses advanced imaging techniques to demonstrate the potential for doubling or even tripling the number of patients who may benefit. Using penumbral imaging to identify salvageable regions of brain, new clinical trials are demonstrating that thrombolytic therapies can be effective well beyond the 3-hour window established with the 1996 approval of recombinant tissue plasminogen activator. Research even suggests that tPA itself can be effective up to 6 hours from stroke symptom onset in patients with an identifiable penumbra.
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