SYDNEY, Australia, Feb. 13 /Xinhua-PRNewswire/ -- Ventracor today reported progress in its US Clinical Trial program and revealed details of its innovative US clinical trial strategy.
Ventracor Chief Executive Officer Peter Crosby said: "Ventracor's overall objective is to reach the end point of US Food & Drug Administration (FDA) approval to market the VentrAssist in the US as soon as possible. Working closely with the FDA on several initiatives, we have received approval for both the Bridge to Transplant Trial and Destination Therapy Trial protocols."
Destination Therapy (DT) Trial
The Destination Therapy 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.
Module B (secondary) consists of up to 45 patients, with randomization of the VentrAssist to an LVAD approved by the FDA for DT.
The Company believes that this innovative trial has the potential to reduce time to market by up to eighteen months compared to earlier DT trials. A patent on this trial design has been applied for.
Bridge to Transplant (BTT) Trial
The BTT Protocol is a single arm prospective trial to an objective performance criterion of 75 percent ± 10 percent 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.
Enrolment in both trials will commence following FDA approval after review of data from patients in the feasibility trial. The DT and BTT Trials will be run concurrently at up to 40 centres.
Implants of the VentrAssist in US clinical trials will be sold on normal commercial terms and will contribute to future revenue growth.
Ventracor is a global medical device company which has developed an implantable blood pump, the VentrAssist left ventricular assist device (LVAD), as therapy to improve the lives of heart failure patients and their families. Ventracor is dedicated to building partnerships with healthcare professionals to make the VentrAssist the standard-of-care worldwide.
Further information, please contact: Peter Crosby, Chief Executive Officer or Andrew Geddes, Manager, Media & Investor Relations T: +61-2-9406 3086 (direct) E: info@ventracor.com.
VentracorCONTACT: Peter Crosby, Chief Executive Officer, or Andrew Geddes, Manager,Media & Investor Relations, +61-2-9406-3086, info@ventracor.com
