Clinical Progress

Ventracor received approval to market the VentrAssist in Europe in December 2006.

Clinical Trials for approval in the US are underway.

We are taking a strategic approach to achieving US regulatory approval in the fastest possible time.

Ventracor is the only company with a third generation LVAD in clinical trials in the US and is earning revenue from sale of the VentrAssist during these trials.

The VentrAssist® Left Ventricular Assist Device (LVAD), is a 3G (third generation) implantable blood pump, designed for long term use in patients with end-stage heart failure - a major and growing public health problem globally.

In the US, the Food and Drug Administration (FDA) requires separate clinical trials for Bridge to Transplant (BTT) and for Destination Therapy (DT).

Ventracor’s Bridge to Transplant trial protocol was approved by the FDA in December 2006 and recruitment is underway.

Bridge to Transplant


The US Bridge to Transplant Pivotal Trial is aimed at establishing both the safety and efficacy of the VentrAssist LVAD for Bridge to Transplant applications. The US Bridge to Transplant Pivotal Trial involves the following steps:

• Patient enrolment;
• Patient follow up to required statistical end points;
• Pre-Market Approval application to the FDA; and
• Receipt of FDA Pre-Market Approval to allow the US to start marketing in the US for the Bridget to Transplant application.

It involves short term use of the VentrAssist LVAD for patients who are awaiting a heart transplant but may deteriorate rapidly before a donor heart becomes available.

The BTT trial is a single-arm prospective trial to test the safety and efficacy of the VentrAssist LVAD in approximately 140 patients with end-stage heart failure who are on the heart transplant waiting list.

The primary endpoint will be achieved with a 75 percent ± 10 percent success rate, defined as the percentage of patients who have a heart transplant or are still listed for heart transplantation at 180 days.

Bridge to transplant is the required regulatory entry point for the US market.

Destination Therapy

The largest potential for the VentrAssist LVAD is the US Destination Therapy market.

In order to obtain the required FDA approval for marketing in the US for the Destination Therapy application, it is necessary to conduct clinical trials.

Ventracor's Destination Therapy trial protocol received conditional approval by the FDA in December 2006 and recruitment is underway at leading hospitals in the US.

Destination Therapy is long term use of the VentrAssist LVAD for patients who are ineligible for a heart transplant and have few other available options.

Ventracor’s Destination Therapy trial is a prospective, randomized, controlled clinical trial aimed at evaluating the effectiveness and safety of VentrAssist as long-term circulatory support for patients with end-stage heart failure who are not eligible for cardiac transplantation.

The primary endpoint of the trial is to achieve statistically significant improvement in survival for patients with the VentrAssist device compared to optimal heart therapy.

The trial has two modules: up to 180 patients will be enrolled in group A and randomized 2:1 to receive a VentrAssist implant within 48 hours, or to continue optimal heart failure therapy (medical management or device therapy); up to 45 patients requiring an LVAD within 48 hours will be enrolled in group B and randomized 2:1 to receive a VentrAssist LVAD implant or a currently approved LVAD DT device.

Once evidence of product safety and efficacy has been established through these trials and FDA approval has been gained, we will be able to commence marketing in the US for this application. The steps involved in this process are:

• Patient enrolment;
• Patient follow up to required statistical end points;
• Pre-Market Approval application to the FDA; and
• Receipt of FDA Pre-Market Approval to allow us to start marketing in the US for the Destination Therapy application in the US.

It is important to note a number of clinical trial and regulatory steps to be taken are outside of the direct control of Ventracor. In addition, unforeseen circumstances might impact upon envisaged timeframes for both the clinical trials and the regulatory approval processes.