Second implant of US Pilot Trial achieved
Ventracor Limited (ASX: VCR) today announced further progress in its US Pilot Trial with a second implant by surgeons at the University of Maryland Medical Center in Baltimore, US.
The implants are part of an FDA-approved pilot trial (feasibility study) involving 10 patients at five hospitals across the US.
Principal investigator Dr Bartley Griffith, Chief of Cardiac Surgery at the University of Maryland Medical Center said a second patient had received the VentrAssist left ventricular assist system (LVAS) last week.
Dr Griffith said: "It (VentrAssist) functions in a way no other pump does. The VentrAssist pumps the same volume of blood as larger pumps, but its small size takes up very little space in the abdomen, potentially making it useful for smaller adults, and even children". Dr Griffith added he thought the surgery had been "another step toward providing the perfect heart pump".
Co-principal investigator, Dr Erika Feller, an assistant professor of medicine and cardiologist at the center, said the surgery was "not as tough on patients as with other devices.
"End-stage heart failure is a growing problem, especially among patients who don't qualify for a heart transplant," she said.
At the same time, the first US patient to receive a VentrAssist smiled and gave a thumbs-up to the Australian-designed blood pump at a hospital media conference on Friday.
"I feel absolutely marvelous," said the 40-year old Baltimore man adding "I'm almost back to my old self."
The patient told the media conference he was looking forward to going back to work and was planning a honeymoon to Las Vegas. He said he was just two days away from making the trip when he became sick.
The VentrAssist has now been implanted in more than 30 patients globally. Other leading hospitals to take part in the VentrAssist US study include the Cleveland Clinic, Columbia University, the University of Minnesota and the University of Pittsburgh Medical Center.
Dr. Griffith is a pioneer in the evaluation and development of a variety of mechanical support devices for the heart. He is Chief of the Division of Cardiac Surgery and Director of Heart and Lung Transplantation in the Department of Surgery at the University of Maryland Medical Center and is a Professor of Surgery at the University of Maryland School of Medicine. Prior to his arrival at the University of Maryland, Dr. Griffith served as Vice Chair, Department of Surgery at the University of Pittsburgh School of Medicine, where he was also Chief of Cardiothoracic Surgery and the Henry T. Bahnson Professor of Surgery.
Congestive Heart Failure affects about five million people in the USA, or two percent of the population. According to the American Heart Association, nearly five million Americans have heart failure; about 550,000 new cases are diagnosed each year, and there are around 45,000 deaths from CHF.
The VentrAssist is a third generation pump which uses centrifugal force to provide blood flow. The VentrAssist was primarily designed as a permanent alternative to heart transplant but for this U.S. study is being tested only as a bridge to transplant, so it is offered to patients who are listed for a heart transplant.
Ventracor is a global medical device company that has developed a blood pump, the VentrAssist
TMleft ventricular assist system (LVAS) for patients in cardiac failure. The company hopes to bring the VentrAssist TMto the global market in record time, and expects to obtain a significant share of the huge potential market.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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