Ventracor Limited (ASX: VCR) today named the five American heart transplant centres that will take part in the feasibility stage of the US clinical trial of its world leading heart assist device.
Ventracor Limited Chief Executive Officer, Colin Sutton PhD, said that Professor Eric Rose of Columbia University will be the Principal Investigator of the study and Professor Robert Kormos of the University of Pittsburgh Medical Center would be Chairman of the Steering Committee.
The sites for the US feasibility study involving 10 patients are Columbia University (New York, NY), University of Maryland (Baltimore, MD), University of Minnesota (Minneapolis, MN) and the University of Pittsburgh Medical Center (UPMC, Pittsburgh, PA), and one other site.
"We are very proud to be working with such a prestigious group of medical centers and investigators," Dr Sutton said. "Ventracor is on track to begin implanting the VentrAssist in our major market, the USA. We are well on our way to realising our vision of being a world leading provider of left ventricular assist devices in this clearly emerging global market," he added.
The announcement was made as Ventracor concluded the first Investigators' Meeting with 40 attendees, in preparations for the pending feasibility phase of the US Bridge-to-Transplant (BTT) trial. The New York meeting was co-hosted by the International Center for Health Outcomes and Innovation Research (InCHOIR), an independent clinical research center based at Columbia University (www.inchoir.org). InCHOIR, the data and clinical coordinating center for the trial, will collaborate with Omnicomm Systems (www.omnicomm.com), an electronic data capture system company.
Professor Eric Rose said: "We are very excited to have the chance to be involved in the clinical trial of this promising new device. The VentrAssist offers some important potential advantages over existing therapies, which we hope will be shown during the clinical trial."
Professor Robert Kormos added: "The clinical trial of any new therapy requires careful consideration and analysis, and we believe this trial is designed to be both manageable and scientifically rigorous."
Also speaking at the meeting were representatives of Vital Engineering (www.vitalengineering.com) who will provide training and field support for the start of the clinical trial. Vital Engineering has experience in over 300 implants of mechanical circulatory support devices, and is highly regarded in the clinical community.
Dr. Eric Rose is Morris & Rose Millstein, Johnson and Johnson Professor and Chairman of the Department of Surgery at Columbia University Medical Center, in New York. Professor Rose led the three-year landmark multi-center clinical research study, known as REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure).
Dr. Robert Kormos is Professor of Surgery, Division of Cardiothoracic Surgery at the University of Pittsburgh School of Medicine and medical director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. In addition, he is co-director of UPMC's Heart Transplant Program.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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