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The Michael E. DeBakey Papers

Title:
The DeBakey VAD pdf (12,526,033 Bytes) transcript of pdf
The DeBakey VAD
Number of Image Pages:
8 (12,526,033 Bytes)
Date Supplied:
ca. 1997
Creator:
Micromed Technology, Inc.
Rights:
The National Library of Medicine's Profiles in Science program has made every effort to secure proper permissions for posting items on the web site. In this instance, however, it has either not been possible to identify or contact the current copyright owner. If you have information regarding the copyright owner, please contact us at profiles@nlm.nih.gov.
Subject:
Medical Subject Headings (MeSH):
Heart-Assist Devices
Exhibit Category:
New Directions for Cardiac Surgery and for Baylor, 1963-2008
Box Number:
8
Unique Identifier:
FJBBPL
Document Type:
Brochures
Language:
English
Format:
application/pdf
image/tif
Physical Condition:
Good
Series: Baylor College of Medicine, 1948-2008
SubSeries: Instruments and Devices, 1959-1968; [1977]; 1988-2004
Folder: DeBakey Axial Flow Pump, 1996-1997
Transcript:
MicroMed Technology, Inc.
The DeBakey VAD
(Miniaturized ventricular assist technology co-developed with Dr. Michael E. DeBakey, Dr. George P. Noon and the National Aeronautics and Space Administration)
[Photograph = A new promise . . . for a better life. (Shows a family on the beach)]
The DeBakey VAD System*
*Caution: Investigational Device - Not for sale
[Diagram = The DeBakey VAD System (Diagram of device showing position in chest)]
MicroMed Technology, Inc. ("MicroMed" or the "Company") was formed in 1995 for the purpose of developing for commercial use a miniaturized, auxiliary heart pump or ventricular assist device known as the DeBakey VAD. The DeBakey VAD, which was jointly developed by the famed heart surgeon Dr. Michael E. DeBakey, Dr. George Noon and the National Aeronautics and Space Administration (NASA), is a miniaturized heart assist device designed to provide increased blood flow to patients who suffer from heart disease. It is capable of pumping in excess of ten liters per minute.
NASA became involved in the development of the pump through the struggle for life of a Johnson Space Center (JSC) engineer, David Saucier. Following a severe heart attack and triple bypass surgery, a team of doctors led by Drs. DeBakey and Noon performed heart transplant surgery. Six months later, Mr. Saucier returned to JSC with the desire to apply spacecraft technology to help people with diseased hearts. Based on the foundation of NASA's technology and engineering along with personnel from Baylor College of Medicine, the design was formulated and development began in 1988.
The Company, which maintains its headquarters in The Woodlands, Texas, and a preclinical manufacturing and assembly facility in Houston, Texas, received an exclusive license for the axial flow VAD in 1006 from NASA. Dr. Michael DeBakey has assigned to the Company the use of his name for the DeBakey VAD in perpetuity and serves as Chairman of the Company's Medical Advisory Board.
The DeBakey VAD is 30 mm x 76 mm, weighs 93 grams (less than 4 ounces) and is 1/10th the size of pulsatile products on the market.
[Diagram = Cutaway view of device]
Projected Patient Benefits
The device may be attached to the ventricle or placed into or through the atrium. It's light weight and miniaturization make a candidate for minimally invasive application versus the time consuming and expensive open procedures required of current products on the market. Initial selling price for the DeBakey VAD system is projected at less than one half the competitive products currently in the market. In addition, the DeBakey VAD design will allow patients the mobility of not pulling a data acquisition system (DAS) around with them as many of the products currently on the market require. Patients are expected to use the DeBakey VAD DAS unit only during their stay in the hospital. The mobility of this design represents a significant ergonomic benefit and cost savings to the users of the DeBakey VAD system over competitive products.
[Diagram = DeBakey VAD relative to heart]
Market
It is estimated that over 3 million Americans and 20 million people worldwide suffer from some form of heart failure. End-stage, Class IV heart failure is a progressive disease which is almost always fatal. The five-year survival rate for heart failure patients is less than 40% and very few live ten years. Presently, patients suffering from heart disease have relatively few options. Heart transplantation is an expensive process which is severely limited by the lack of availability of donor hearts. Although there are ventricular assist devices on the market today, these units are large, bulky and expensive. The Company's mission is to provide a safe, low-cost, miniaturized ventricular assist device that is initially indicated for use by approximately 50,000 patients globally as a bridge-to- transplant. However, the potential for the DeBakey VAD is for both the Class III and Class IV patient populations. Class III patients could potentially use the device as a "bridge-to-recovery" in helping the heart muscle repair itself during the device assist.
The company intends to introduce the DeBakey VAD in selected international markets as a left ventricular cardiac assist device for bridge-to-transplant in patients with chronic end-stage heart failure and/or as a long-term alternative to transplant in selected patients with chronic end-stage heart failure and no other viable medical option. In United States, it is expected that the device will initially be used as a left ventricular cardiac assist device for bridge-to-transplant for patients with chronic end-stage heart failure, as well as a left ventricular cardiac assist device for rescue in cases of acute myocardial infarction or failure to wean from cardiopulmonary bypass.
The company believes it will accomplish the necessary milestones to enable Drs. DeBakey and Noon to assist select international surgeons in the first human implantation of the DeBakey VAD device in the second half of 1998. Due to more complex regulatory process in the United States, the company expects to file an investigational device exemption (IDE) in the second half of 1998, and begin USA clinical trials in 1999. Successful clinical trials in the USA would result in FDA approval to market sometime after the year 2000.
The DeBakey VAD is currently manufactured at the company's preclinical assembly plant and computerized CNC mills and dedicated lathes. The company will need to contract with a third-party that manufacturers Class III medical devices under ISO 9000 and Current Good Manufacturing Practices (CGMP) to meet international guidelines for clinical trials.
The Company's product development plan focuses on the goal of achieving human implantation of the DeBakey VAD internationally by the second half of 1998. The goal is achievable through the realization of the following objectives:
1. The Company's initial objective enthalpy acceleration of in vivo testing of the currently designed, hydraulically sound pump by increasing the number of individual in vivo trials. The increased in vivo testing provided additional base data to ensure that information are gathered was accurate in that the pump only causes minimal but acceptable blood damage and, in the worst case, minimal but acceptable levels of thrombosis. The intent is to further demonstrate that the DeBakey VAD is safe. The Company began using biocompatible titanium versus original models of medical grade polycarbonate in December 1996. This material change should significantly extend the length of time that the DeBakey VAD can remain implanted without deterioration. The final design of the DeBakey VAD was frozen in March 1997.
2. The Company needs to understand bearing wear characteristics and their effect on long-term pump performance. The company contracted with Tracor Applied Sciences, Inc., a major aerospace corporation specializes in "fault to failure" vibrational/acoustical testing. The objective of this relationship is to perform bearing durability and long-term pump durability studies. Ten DeBakey VADs has been running continuously 24 hours per day in saline solution since May 1997 with no indication anywhere in the bearings or pumps. Additional pumps were tested with artificially induced where to establish where signature characteristics as well as the effect of various levels of where on hemolysis and pump performance. Results to date indicate that the DeBakey VAD bearings should have a life expectancy well in excess of one year. The studies are continuing.
3. The Company has contracted with two companies to provide the ancillary support systems for the DeBakey VAD". Hi-tronics Designs, Inc., an electronics design and manufacturing corporation with extensive experience in developing and manufacturing cardiac implantable devices, is developing the external controller. SeaMED Inc. is developing the Clinical Data Acquisition System (CDAS). SeaMED has extensive experience with medical device requirements and is IS0 9001 qualified. Hi-tronics and SeaMED are also contracted to provide documentation and validation of the controller and CDAS to accompany MicroMed's international and FDA regulatory applications.
[Photograph = DeBakey VAD Controller]
[Photograph = Clinical Data Acquisition System (CDAS)]
4. The next generation of the DeBakey VAD with the miniaturization of the controller to approximately the size of a pacemaker, totally implantable with power provided through a transcutaneous energy transfer system or TETS (versus the percutaneous approach and the current generation). Pump operating parameters and diagnostic information will be communicated via telemetry, minimizing the need for the patient to travel to the hospital or physician's office.
The complete DeBakey VAD system is being tested in vivo and Company's preclinical testing sites at the University of Utah, Artificial Heart Laboratory (Salt Lake City, UT) and at Texas A&M University's Texas Agricultural Experiment Station (College Station, TX). The Company anticipates beginning final in vivo safety trials in mid-1998.
The combined efforts of Drs. DeBakey and Noon, the NASA scientists and engineers at Johnson Space Center and Ames Research Center, scientists at the University of Utah, Texas A&M, Baylor University, engineers at Hi-tronics Designs, SeaMED Corporation, Tracor Aerospace, and MicroMed Technology have brought David Saucier's hope to the threshold of reality.
A new promise . . . for a better life.
[Photograph = Dr. DeBakey holding a miniaturized DeBakey VAD and a currently marketed pulsatile VAD]
Key Personnel
Officers
Dallas W. Anderson, President and Chief Executive Officer
Donald V. Olsen, D.V.M. Vice President of Research and Development
Travis E. Baugh, Vice President and Chief Financial Officer
Operating Management
Robert Benkowski, Director of Engineering
Bryan Lynch, Director of Operations
Deborah Morley, Ph.D., Director of Regulatory Affairs and Clinical Trials
Timothy Placek, Director of Quality Assurance
Medical Advisory Board
Dr. Michael E. DeBakey, Chairman
Chancellor Emeritus of Baylor College of Medicine and Director of the DeBakey Heart Center at Baylor and the Methodist Hospital
Medical Advisory Board Members
Dr. Jack G. Copeland
Professor and Chief, Section of Cardiovascular and Thoracic Surgery
The University of Arizona, Tucson, Arizona
Prof. Dr. Marco Turina
Prof. and Director, Clinic for Cardiovascular Surgery; Dean, Medical Faculty
University of Zurich, Zurich, Switzerland
Prof. Dr. Roland Hetzer
Chairman and Chief Cardiothoracic Surgeon
Deutsches Herzzentrum, Berlin, Germany
Dr. Vallee L. Willman
Professor/Chairman Emeritus, Department of Surgery
St. Louis University Health Sciences Center
St. Louis University, St. Louis, Missouri
Dr. George P. Noon
Clinical Professor of Surgery
Baylor College of Medicine/Methodist Hospital
Houston, Texas
Prof. Dr. Ernst Wolner
University Clinic - Heart and Thoracic Surgery
University of Vienna, Vienna, Austria
Dr. Stephen J. Phillips
Medical Director
Iowa heart Institute, Des Moines, Iowa
Dr. James B. Young
Professor and Head, Section of Heart Failure and Cardiac Transplant Medicine
The Cleveland Clinic Foundation, Cleveland, Ohio
Corporate offices:
Headquarters
1610 Woodstead Ct., Suite 360
The Woodlands, TX 77380
(281) 298-7555
(281) 298-7884 fax
Preclinical Manufacturing Facility
8965 Interchange Drive
Houston, TX 77054
(713) 838-9210
(713) 838-9115 fax
Metadata Last Modified Date:
2017-07-20
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