ventracor manufacturing ramp up and 4g, page-5

Blakes7,

I posted an message a couple of weeks ago in relation to trial centres. At that stage only 1 out of 20 centres were currently recruiting patients.....this is why we haven't had the expected rise in implants.

This will inevitably change as more centres come on board which I hope is not too far away.

Also, VCR is able to use an alternative LVAD for part of its US trials....

Destination Therapy (DT) Trial
The DT Protocol is a prospective, randomized, controlled trial with two modules. Both modules have event driven end points.

Module A (primary) consists of 180 patients with 2:1 randomization of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT.

Bridge to Transplant (BTT) Trial
The BTT Protocol is a single arm prospective trial to an objective performance criterion of 75%±10% success, defined as heart transplantation or listed for heart transplantation at 180 days. There will be an interim analysis at 98 outcomes. Data from patients in the feasibility trial may be pooled with data from patients in the pivotal trial.

So the 4G device can be used....thats the way I read it.

Module B (secondary) consists of up to 45 patients, with randomization of the VentrAssist to an LVAD approved by the FDA for DT.