Penumbra, Inc., the market leader in intra-arterial stroke treatment, announced that an independent study published online in the New England Journal of Medicine found that intra-arterial stroke treatment, including the company's clot extraction technology, was shown to be significantly more effective than medical management with tissue plasminogen activator (tPA), which is the current standard of care. The findings of this randomized, controlled comparative effectiveness trial of stroke treatment have the potential to change the standard of care and improve functional independence for the 15 million stroke patients worldwide who currently have few treatment options.
In the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) comparative effectiveness study, intra-arterial treatment improved the rate of good functional outcome by 71 percent over treatment with medical management with tPA alone. Of patients who received intra-arterial treatment, 32.6% achieved a clinically defined positive stroke outcome compared with 19.1% of those who received medical management. Intra-arterial treatment was beneficial for all ages (18+), including the elderly (80+) - a population for whom intervention was previously thought to be risky. The trial began enrolling in 2010 and participating physicians used earlier generation intra-arterial technology. Currently available technology continues to improve upon the baseline set by MR CLEAN.
MR CLEAN also demonstrated:
- Intra-arterial treatment was effective for patients with the most common and devastating form of stroke, LVO (large vessel occlusion), for which tPA is less effective.
- Intra-arterial treatment is effective up to 6 hours after stroke onset vs. 3 to 4.5 hours for tPA.
- Both treatments were safe, with no differences relating to hemorrhage or mortality.
"The MR CLEAN study results provide evidence to support intra-arterial treatment in the fight against stroke and have the potential to change the standard of care," said Adam Elsesser, chief executive officer, director and founder, Penumbra. "Penumbra is proud to have supported the MR CLEAN trial, and these important results will aid our efforts to improve access to intra-arterial treatment for the millions of stroke patients around the world."
Penumbra provided an unrestricted grant for the trial, and its devices were among those included in the protocol. Companies providing grants had no influence over the trial's design or execution. Penumbra's newest intra-arterial treatment, which was not available at the time MR CLEAN was conducted, is the ACE™, a next generation clot extraction system that uses aspiration alone to engage and remove blood clots causing an acute ischemic stroke. Results with the Penumbra ACE system continue to improve upon the baseline set by MR CLEAN.
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