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VentrAssist LVAD Shows 83% Success Rate in Bridge-to-Transplant Trial

Strategic Insights

— 1 min read

Results from the VentrAssist left ventricular assist device (LVAD) CE Mark Bridge-to-Transplant Trial have been presented at the European Association of Cardiothoracic Surgeons (EACTS) in Sweden. The trial, which involved patients aged 10 to 75 years, achieved an impressive 83% success rate in meeting the primary clinical end-point of cardiac transplant or continued transplant eligibility at 154 days after a VentrAssist implant. This success rate is significantly higher than that of earlier published results from first-generation devices, which reported a 65% success rate. The adverse event rate was consistent with expectations, and no deaths were related to device malfunction during the CE Mark Trial.

Key Takeaways:

  • The VentrAssist LVAD showed an 83% success rate in the CE Mark Bridge-to-Transplant Trial, significantly better than the 65% success rate of first-generation devices.
  • The trial involved patients aged 10 to 75 years with end-stage heart failure requiring circulatory support as a bridge-to-heart transplantation.
  • The longest duration of continuous support was 977 days, demonstrating the device's ability to provide long-term support for patients.
  • No deaths were related to device malfunction during the CE Mark Trial, highlighting the safety and reliability of the VentrAssist LVAD.
  • The VentrAssist has a high output and inherent flow regulation that mimics normal physiology, making it an attractive option for patients with heart failure.
  • Ventracor has started the Baseline Results and Cost Effectiveness (BRACE) Study in Europe to further establish the clinical performance and cost-effectiveness of the VentrAssist LVAD.

Statistics:

  • 83% success rate in the CE Mark Bridge-to-Transplant Trial (Source: Ventracor)
  • Longer duration of continuous support (977 days) compared to first-generation devices.
  • Age range of patients in the trial: 10 to 75 years (Source: Ventracor)
  • No deaths related to device malfunction during the CE Mark Trial (Source: Ventracor)

Sources:

  • Ventracor's press release, dated September 12 (Source: MediaNet International-AsiaNet)
  • European Association of Cardiothoracic Surgeons (EACTS) (no specific date mentioned)
  • Ventracor's website (www.ventracor.com)

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