Any recommendation from FDA for artificial Heart Mate 2, thanks?

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  • 1 decade ago
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    This article you may find interesting:

    About one of every 500 Americans over the age of 45, or about 200,000 people, has severe heart failure. That number far outstrips the annual supply of 2,000 donor hearts.

    Since the 1960s, physicians have sought to replace the heart's left ventricle, which does a majority of the heart's pumping work, with mechanical devices. Among the early experimenters with these assist devices was Dr. Michael DeBakey, chairman emeritus of Baylor College of Medicine.

    DeBakey's work is associated with another continuous-flow pump, the MicroMed DeBakey pump, which also is undergoing tests for FDA approval.

    "I was pleased to see that they obtained such good results," DeBakey said of the HeartMate II study. "Hopefully, a report like this will strengthen the views of those who are in the field, and that they will look forward to using these pumps."

    A third continuous-flow pump, the Jarvik 2000, is also in the testing phase.

    The HeartMate study was supported financially by Thoratec, the company that makes the pump and its predecessor.

    Including surgical implantation, the HeartMate II costs about $100,000.

    "We are encouraged by the positive outcomes reported from the pivotal study for HeartMate II," said Gary Burbach, president and CEO of Thoratec.

    Physicians awaited the new study's results because the original HeartMate and other pulsatile devices, such as Novacor's WorldHeart, are considerably larger and do not fit all patients. The older pumps have also been found to be noisy and less comfortable than the HeartMate II.

    And, perhaps most importantly, the earlier generation of pumps has a proven durability of just 12 to 18 months.

    'A significant advance'

    In contrast, physicians expect the new continuous-flow pumps, in addition to being smaller and more quiet, to last at least five years. A downside is that patients on the newer pumps must take blood thinners to prevent clotting. The technology also has not totally solved some complications, such as infection and bleeding.

    Because they are easier to implant, patients receiving the new continuous-flow pumps can leave the hospital sooner. Some have taken up bike riding or returned to hobbies such as woodworking, said one of the new study's lead authors, Dr. Francis Pagani, a heart surgeon at the University of Michigan.

    "Combined with quality-of-life improvements, the durability represents a significant advance," Pagani said.

    The original HeartMate is the only heart pump now approved for "destination therapy," the FDA's term for a long-term support device.

    The FDA will review the newer HeartMate for approval as a "bridge-to-transpla nt" device, which could be used only until a patient undergoes a heart transplant. But already Frazier, Pagani and others are enrolling patients in a longer-term test required for the device's approval as "destination therapy."

    Such approval, Frazier said, could come by 2009 if the HeartMate II performs as expected. For Frazier, that's not soon enough.

    "I'm glad we've had this success, and I'm confident the device will continue to work well," he said. "But I have mixed feelings about this, because it takes so long to bring the pumps to patients because of all the required trials."

    Source(s): I am a doctor.
  • Anonymous
    1 decade ago

    The Heart Mate II is still an experimental device that has not yet won FDA approval; therefore, you will not find any information from them pertaining to it. It is a new Left Ventricular Assist Device (LVAD) which helps a sick heart to pump blood out to the body.

    At the facility where I work, I have seen it used on patients as a bridge-to-transplant device. However, the intent of it is to be used as destination therapy, which basically means it will be a permanent device for heart failure patients who do not qualify for a transplant.

    The main advantages to it are that it is smaller, lighter and quieter than older devices. It is also expected to last longer because it has fewer moving parts than the older HeartMate I.

    Here are a few places to give you at least an overview of it, though.

    http://www.thoratec.com//thoratec-patients/heartma...

    http://www.texasheart.org/Research/Devices/thorate...

    http://www.nlm.nih.gov/medlineplus/news/fullstory_...

  • 1 decade ago

    the FDA does not give recommendations on experimental treatments.

    Source(s): RN
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