Healthcare Industry News:  circulatory support 

Devices Cardiology

 News Release - September 12, 2006

Ventracor Clinical Trial Results Released at European Launch of VentrAssist Left Ventricular Assist Device (LVAD)

Key points:
  • Bridge to Transplant (BTT) Trial results: 83% success to end-point
  • 33.3+ years of accumulated experience
  • Longest duration of 977 days continual support
  • Age range of patients 10 to 75 years
  • No deaths related to device malfunction in CE Mark Trial.


The primary clinical end-point of the trial was cardiac transplant or continued transplant eligible at 154 days after a VentrAssist implant.

The VentrAssist left ventricular assist device (LVAD) showed 83 percent success rate in the trial which is significantly better than the earlier published results of first generation devices, reported to be 65 percent. The adverse event rate was in line with expectations.

Ventracor Chief Executive Officer Peter Crosby said: "We are very pleased about these results, and hope to start selling the VentrAssist in Europe with a CE Mark in early 2007."

"We believe that these results and more than 33 years of cumulative patient support and clinical experience will help us secure a major position in the global LVAD market.

"Heart surgeons and cardiologists from around the world who attended the European Association of Cardiothoracic Surgeons (EACTS) in Sweden this week were very excited about these results," Mr Crosby said.

The purpose of Ventracor's CE Mark Trial was to establish clinical performance of the VentrAssist for use in patients with end-stage heart failure requiring circulatory support as a bridge-to-heart transplantation.

The clinical results are the subject of a major report which is expected to be submitted soon as the next step to obtain CE Mark approval.

"We recognize wide market acceptance needs more than regulatory approval, and we have started the Baseline Results and Cost Effectiveness (BRACE) Study in Europe.

"We anticipate the results of the BRACE Study will reinforce the results of the CE Mark Trial, and provide a strong platform of evidence for future marketing.

About VentrAssist

VentrAssist is a third generation centrifugal implantable blood pump designed for long-term use in patients with advanced heart failure. It is primarily designed as therapy for patients who are not eligible for a heart transplant, as well as for use as a bridge-to-transplant and as a potential bridge-to-recovery. The VentrAssist has a high output and inherent flow regulation that mimics normal physiology. The device has been designed so patients require minimal anticoagulation. The blood pump has no wearing parts.

About Ventracor

Ventracor is a global medical device company which has developed a blood pump, the VentrAssist left ventricular assist device (LVAD) for patients with heart failure.

Further information, visit http://www.ventracor.com or contact Andrew Geddes Ventracor Limited info@ventracor.com or + 61 2 9406 3100 or + 61 2 9406 3086.


Source: Ventracor

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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