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Final Published Trial Data in The Lancet Supports Safety and Effectiveness of MicroVention-Terumo's HydroCoil® Embolic System for Treatment of Cerebral Aneurysms
Date:5/31/2011

oCoil implant is a non-bioactive coil that combines platinum with an expanding hydrogel polymer which provides the features of greater aneurysm volume filling with biologically inert material for natural tissue proliferation.

Angiographic results from an independent core lab indicated there was a statistically significant decrease (8.6%) in major aneurysm recurrence with the HydroCoil system arm as compared to bare platinum control arm.  Aneurysms in the trial ranged in size from 2 mm to 25 mm, and 84% of all aneurysms were medium and large in size.

Key results of the trial demonstrated:

  • HydroCoil implants had statistically significant more stable angiographic results with a significant decrease in major remnant/recurrence rates.
  • The primary composite endpoint, while neutral, showed a strong trend favoring the HydroCoil Embolic System.
  • There was a very low retreatment rate: 3% HydroCoil system arm vs. 4% bare platinum control arm.
  • The effect of the HydroCoil system on outcomes was superior in ruptured aneurysms:  68% HydroCoil implants vs. 50% bare platinum implants.
  • The HydroCoil system had less thromboembolic complications: 5.6% vs. 10% with bare platinum(1).
  • HydroCoil implants resulted in a higher packing density with less coil length (reduction of 20%(1) as compared to bare platinum) due to its expansion properties:  63.9% for HydroCoil implants and 23.2% for bare platinum implants.  
  • Outcomes were superior when the targeted amounts of HydroCoil implants were achieved in aneurysms (>50% HydroCoil implant length per protocol).

"We are very pleased with the exceptional results from this landmark trial.  It continues to validate findings from previous multi-center and single-center trials, which is that the HydroCoil system provides excellent results in reducing aneurysm recurrence and retreatment in a w
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SOURCE MicroVention-Terumo, Inc.
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