Proven Accuracy in Clinical & Experimental Flow Measurement
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MicroMed Technologies Inc., Woodlands, TX, offers the
DeBakey VAD®, a miniaturized heart assist device designed to provide increased blood flow to patients with heart disease.
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DeBakey VAD
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Dr. Michael Debakey
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Developed by famed heart surgeons Dr. Michael E. DeBakey and Dr. George P. Noon
in collaboration with the National Aeronautics and Space Administration (NASA), the pump is a safe, miniaturized ventricular assist device capable of pumping up to
10 L of blood per minute. Following successful clinical trials in Europe, the FDA has granted conditional approval for MicroMed to begin a multi-center clinical study for
the device in the USA. Customized flowboards and flowprobes, developed by Transonic Systems in collaboration with MicroMed engineers, are used in the VAD.
According to the MicroMed news release, the clinical trials will occur at approximately 20 sites and implants of the device will occur in an estimated 178
patinets. Transonic technology will be used in each of these implants. While viewed
primarily as a "bridge to transplant," the DeBakey VAD® is also envisioned by its developers as a "bridge to myocardial recovery."
Early in their project, in February 1997, MicroMed engineers contacted Transonic
Systems to provide a miniaturized flow system that would meet the pump's tight mechanical and electrical specifications. A Transonic sensor was custom designed
to be positioned on the VAD's outflow cannula to measure actual pump flow. A percutaneous cable leads from the sensor to a miniaturized Transonic flow board
housed in the pump's battery pack which is worn on the patient's waist.
Transonic Systems is proud of its unique participation in this project which
potentially benefits some of the 5 million American and 20 million people worldwide who suffer from heart disease
MicroMed Technology To Conduct Clinical Trial for Physiologic Algorithm
First of kind study reveals insight into how a continuous flow VAD responds to a Chronic Heart Failure patient's exercise needs
HOUSTON-March 13, 2002- MicroMed Technology, Inc. announced today the
completion of a two-year waveform analysis involving more than 100 patients to determine the most efficient control of a continuous flow VAD to increase blood
flow and avoid ventricular suckdown as heart failure patients recover and want more strenuous exercise.
Over the course of two years, MicroMed Technology, in collaboration with the
University of Vienna, Austria, has developed a physiologic algorithm using a comprehensive database of 1000+ snapshots of over 100 patients' VAD flow
waveforms. These were collected using the sophisticated flow probe data acquisition system, part of the DeBakey VAD® system. The snapshots contain
instances of normal flow, pulse-less flow, arrhythmias, ventricular fibrillation, and ventricular suction. MicroMed developed the software application to analyze these
snapshots to extract various physiologic and VAD parameters.
This study gave MicroMed crucial information needed to help heart failure patients
that has been unobtainable until now. With the results of this two-year study, MicroMed will continue by launching a clinical trial in mid 2002 - initially in Europe
and later in the United States.
"The MicroMed DeBakey VAD® is the only continuous flow device using an implanted
flow probe and data acquisition system from which we have collected more than 1000 human blood flow patterns. This database of actual clinical waveforms has
formed the basis for our physiologic algorithm that would be difficult, if not impossible, to determine from healthy animal and mock loop studies. The need to
base a physiologically responsive VAD on data directly from heart failure patients is critical," said Bob Benkowski, Vice President of Engineering at MicroMed.
"This is good news for our future DeBakey VAD® alternative-to-transplant patients,"
said Dallas Anderson, President and CEO of MicroMed Technology. "With the use of this algorithm, patients can expect: improved ergonomics and increased battery life
as the pump speed responds to body demands; increased exercise capability as blood flow increases during exercise; and improved safety as the pump detects
blood volume loss or right heart failure."
MicroMed Technology, Inc., is a privately held company that develops products for
patients with end-stage, congestive heart failure (CHF). MicroMed's primary product is the DeBakey VAD®, a miniaturized axial flow heart-assist pump that
measures one by three inches and weighs less than four ounces. The DeBakey VAD® has the CE Mark and is in Phase III clinical trials in the United States. MicroMed's
headquarters and ISO 9001certified manufacturing facility are located in Houston, Texas. For more information, visit www.micromedtech.com <<http://www.micromedtech.com>>.
The DeBakey VAD® system is an investigational device in the United States and is
limited by federal law for investigational use in the United States.
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Complications common to ventricular assist device support are rare with 90 days of DeBakey VAD® support in calves.
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