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    Press Release Source: MicroMed Technology, Inc.


    MicroMed Technology, Inc. Achieves Major Milestones: 200th Patient Implant of The DeBakey VAD(R); FDA IDE Pivotal Trial Approval for Destination Therapy; FDA Submission for Pediatric Patient Indication.

    Thursday August 14, 8:04 am ET


    HOUSTON, Aug. 14 /PRNewswire/ -- MicroMed Technology, Inc., the global leader in miniaturized heart pump technology, announced today it has achieved a significant milestone of implanting 200 patients with the MicroMed DeBakey VAD®. The device, designed for end-stage heart failure patients who can no longer provide necessary blood flow with their native heart, is the size of a "C" cell battery, is silent, weighs less than four ounces and was designed by NASA for long-term use.
    Marking this milestone were two patients implanted with the device on July 25, by Dr. Georg Wieselthaler in Austria, at the University of Vienna, AKH, and Dr. Ettore Vitali in Italy at Ospedale Niguarda Ca' Granda, Milan. According to the doctors, prior to the implantation of the MicroMed DeBakey VAD, the condition of both patients rapidly deteriorated and required support with multiple medications to maintain adequate blood pressure. After progressively worsening, they underwent successful placement of the DeBakey axial flow VAD.

    According to Dr. Vitali, his 67 year-old male patient suffered from devastating congestive heart failure after a severe acute myocardial infarction. "There were several reasons why we used the DeBakey VAD in this case," said Dr. Vitali. "Because of the patient's age, he was not considered for a transplant, and a first generation pulsatile pump would be too invasive in surgical and biological terms. The DeBakey VAD enabled us to perform a quick, safe and minimally invasive operation, and it assured a long-term superior cardiac output with a low rate of thromboembolic complications without mechanical failure. His prognosis at this time is very good, and I anticipate a hospital discharge soon. After that, we'll consider whether to put him on a list for heart transplantation with marginal donors or take destination therapy into consideration."

    Dr. Wieselthaler explained that his 49 year-old male patient suffered from idiopathic cardiomyopathy. "This was the 31st patient implanted at the University of Vienna, AKH," added Dr. Wieselthaler. "The ease of implantation, reliability, small size and silence are the major reasons why we use the MicroMed DeBakey VAD in our patients."

    "We are very pleased that we have reached this milestone that represents continued market acceptance of our miniaturized technology," said Dallas Anderson, President and CEO of MicroMed. "We are grateful that world renowned cardiac surgeons and cardiologists in key heart centers helped us reach this milestone, along with their continued support in our new patient trial indication of Destination Therapy."

    MicroMed, currently in its 20 site Bridge-to-Transplant pivotal clinical trial in the United States, has also reached a second milestone-approval from the FDA to begin its Destination Therapy pivotal clinical trial. This trial is designed to evaluate long-term support with the DeBakey VAD, and will be a randomized controlled trial for patients who are ineligible for cardiac transplants. The patient population targeted by the approved MicroMed protocol mirrors that of the recently approved REMATCH trial. The Destination Therapy patient population is projected to be significantly larger than the Bridge-to-Transplant market.

    MicroMed has also recently submitted an application to FDA for approval of the pediatric patient indication and hopes to have commercial approval in this "orphaned population" prior to year-end 2003.

    The Technology

    The MicroMed DeBakey VAD is the result of a unique collaboration between NASA, Dr. Michael E. DeBakey, Dr. George Noon, Baylor College of Medicine, and MicroMed Technology, Inc. Originally developed by NASA for long-term applications, the DeBakey VAD has been awarded the CE Mark in Europe and is in its Bridge-to-Transplant pivotal trial in 20 centers in the United States.








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