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FDA Rejects Artificial Heart

Posted by timothy on from the stagnation-safer-than-progress dept.

Mad_Rain writes "Those people who fear cyborgs can rest easy. The Food and Drug Administration voted to reject Abiomed's request to sell artificial hearts to people who have suffered heart failure and exhausted their treatment options. The FDA stated that there was too little gain with too many adverse side effects in the limited trial run (17 people underwent the procedure). Although this isn't quite the same product mentioned in previous Slashdot coverage, it does seem like a setback towards replacing failing organs with fully artificial ones."

4 of 207 comments (clear)

  1. I wonder if some side effects could be by ZombieChiefExecutive · · Score: 5, Funny

    psychological. Imagine walking around knowing you had no heart? Spooky.

    --
    James Buchanan
    Zombie Chief Executive/15th President of the USA
    1. Re:I wonder if some side effects could be by albeit+unknown · · Score: 5, Informative

      You are describing a Left Ventricular Assist Device (LVAD). That's not what this is.

      The Abiomed device is a Total Artificial Heart (TAH). They cut out your existing left and right ventricles and install this in their place. If the device fails, you die instantly.

      For what it's worth, I participated in the first calf trial of this device at Louisville.

  2. Why? by TheGavster · · Score: 5, Interesting

    I never understood 'cure for death' type devices getting shot down. Like, your heart is going to stop and you will die, but we could perform $risky_medical_proceedure and there's a 10% chance you'd live. That's pretty lousy survival for say, cough drops, but not all that bad when faced with certainty of death.

    --
    "Because Science" is one step from "Because old book". Try "Because of my experiment testing my falsifiable assertion".
  3. Not the only device... by Achra · · Score: 5, Informative

    As has been mentioned, this _is_ a bit of a step backward. However, the Abiomed device is an actual artificial heart.. This is much more complicated than the accepted alternative, the left ventricle assist (LVAS). The idea is, they stick this motor in the side and bottom of your heart, and turn it on. No chambers required, no pulse necessary. Constant Flow. Makes me wonder how well the brain would operate without a pulse though.. Would it effect your moods? I'm not sure, but as this is a press release, I don't _think_ it violates my NDA. http://www.terumo.co.jp/English/press/2004/04_01.h tml/

    --
    Each processor would proceed sequentially as if it had been better for them not to rise against Saul.