Fifth VentrAssist implant in US feasibility trialVentracor Limited (ASX:VCR) today announced five American patients had been implanted with the VentrAssist cardiac assist system in the United States.
The most recent procedure was performed by a team led by Yoshifumi Naka M.D. at the Columbia University Medical Centre in New York.
Dr. Naka said: "We are very excited about participation in the clinical trial of the VentrAssist. It is the only third generation centrifugal LVAD available for clinical trial in the US, and we look forward to seeing the results of the clinical trials."
"We are now half-way though the first phase of the US clinical trial program and importantly, on track to complete recruitment this quarter," Ventracor Chief Executive Officer Colin Sutton PhD said.
Dr Sutton added the company also expected the completion of recruitment this quarter in its CE Mark Trial aimed at approval to sell the VentrAssist in Europe.
"By meeting these clinical milestones, Ventracor continues to show its determination to be a leading company in the global LVAD business," Dr Sutton said.
The Columbia University Medical Centre is one of five leading US centres participating in the company's US clinical trial program which will lead to a submission for approval to market the revolutionary third generation blood pump and patient management system in the US.
The trial is managed in part by the International Centre for Health Outcomes and Innovation Research (InCHOIR).
Dr. Naka is the current Herbert Irving Assistant Professor of Surgery at Columbia University College of Physicians & Surgeons, New York, NY and Director, Cardiac Transplantation Program, Columbia University Medical Centre New York. He is also Director of the Mechanical Circulatory Support Program at the Columbia University Medical Centre. His clinical specialties include adult cardiac surgery, valvular heart disease, heart/lung transplantation and mechanical circulatory support device implantation.
Congestive Heart Failure In the United States, congestive heart failure (CHF) affects about five million people, or two percent of the population. There are an estimated 550,000 new cases diagnosed each year, and around 45,000 deaths from CHF.
The VentrAssist The VentrAssist third generation blood pump and patient management system has been designed and manufactured for long-term use in patients with 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 been implanted in patients ranging in age from 10 years to 76 years old. The device has no wearing parts. The VentrAssist has a high output and inherent flow regulation that mimics normal physiology. The device has been designed so patients require minimal anticoagulation. In the US, the procedure for implantation of an LVAD is reimbursed under DRG103.
Ventracor is a global medical device company that has developed a blood pump, the VentrAssist left ventricular assist device (LVAD) for patients in heart failure. The company has a history of meeting aggressive milestones and expects to bring the VentrAssist to the global market in record time, and obtain a significant share of the huge potential market.
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