Healthcare Industry News: Exubera
News Release - September 30, 2008
The Modern DeBakey VAD(TM) To Be Introduced For the First Time in the U.S.
HeartAssist 5(TM) Pediatric VAD Features Industry Exclusive Direct Blood Flow Measurement SystemHOUSTON--(HSMN NewsFeed)--The HeartAssist 5™ Pediatric VAD will be introduced for the first time in the U.S. at the 16th annual meeting of the International Society for Rotary Blood Pumps (ISRBP) in Houston on Oct. 2-4.
The Modern DeBakey VAD™ is the only pediatric ventricular assist device (VAD) that benefited from years of hands-on leadership and support by Dr. Michael DeBakey. It is the only VAD to feature the DeBakey name and the only FDA-approved pediatric VAD in the world.
Originally created through a collaboration between Dr. DeBakey, colleague Dr. George Noon, NASA and the Baylor College of Medicine, it is one of the smallest VADs in the world. It can support the failing left ventricle of the heart with blood flow of 1-10 L/min.
The U.S. introduction of the HeartAssist 5™ Pediatric VAD, The Modern DeBakey VAD™, occurs less than three months after the internationally renowned surgeon’s death from natural causes. Dr. DeBakey passed away at age 99 on July 11. He would have celebrated his 100th birthday on September 7, 2008.
Rodger G. Ford, who led the buyout of then public MicroMed Cardiovascular, Inc. and took the company private on August 25, 2008, described his meetings with Dr. DeBakey as “…a humbling experience. I left our meetings Exuberant at Dr. DeBakey’s interest and support.”
The HeartAssist 5™ Pediatric VAD is the only VAD with the exclusive direct flow measurement system, which provides measurement of blood flow through the VAD. Since pediatric VADs are designed to support failing hearts in children, precise blood flow measurement can prove vital for patients in critical condition. At best, other devices only approximate blood flow, which can be unreliable, or provide no blood flow data at all.
The HeartAssist 5™ Pediatric VAD pump weighs only 92 grams and measures just 2.8 x 1.2 inches. Because of its small size, it is one of the few pediatric VADs that can be implanted above the diaphragm in the pericardial space surrounding the heart, which reduces the risk of complications.
Dr. DeBakey will be honored multiple times during this week. On the evening of Oct. 1, Dr. Noon and heart assist device leaders will celebrate the grand re-opening of the International Center for Medical Technologies museum and hold an ISRBP presidential reception in honor of Dr. DeBakey
The following afternoon at the opening session of ISRBP, Dr. Noon and associates will pay tribute to Dr. DeBakey and his lifelong accomplishments in heart surgery and the DeBakey VAD®. There will also be a Tribute to Dr. Michael E. DeBakey and Awards Gala on Oct. 3.
In 1995, with the help of Drs. DeBakey and Noon, MicroMed Cardiovascular was formed to license and commercialize NASA technology. The result of their work was the first human implant of a rotary ventricular assist device, the DeBakey VAD®, in 1998.
In the U.S., the HeartAssist 5™, formerly DeBakey VAD® Child, is the only FDA-approved pediatric VAD and a bridge-to-transplant IDE clinical study is underway for adult use. In Europe, the HeartAssist 5™ is CE Mark approved for both adult and pediatric use. The HeartAssist 5™ Straight VAD is CE Mark approved for patients with previous surgeries or complicated anatomies. It is designed to be implanted through the less invasive left thoracotomy.
Humanitarian Device: The HeartAssist 5™ Pediatric VAD is authorized by Federal law for use in providing temporary mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients 5-16 years old who are listed for transplant. The effectiveness of this device for this use has not been demonstrated.
Source: MicroMed Cardiovascular
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