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  • 2nd recall for Guidant

    Guidant issues 2nd warning on defibrillators

    Associated Press
    Published June 25, 2005


    INDIANAPOLIS -- Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of the models because they could malfunction and may have to be recalled.

    The announcement covered two devices that the company said last week could be repaired with reprogramming in a doctor's office: the Renewal 3 and the 4 AVT models. It also covers the Contak Renewal 3 and 4, and Renewal RF plans.

    Last week, Guidant issued a worldwide recall of more than 40,000 surgically implanted cardiac defibrillators because of potential electrical malfunctions in the devices. Seven models were involved in that recall.

    Shares of Guidant, the world's second-biggest maker of cardiac defibrillators, behind Medtronic Inc., sank more than 12 percent Friday before rallying to close at $63.90, down $4.70, or nearly 7 percent, on the New York Stock Exchange. It was their biggest drop in six months.

    Guidant's recall last week was the second major defibrillator recall this year.

    A Medtronic recall in February has resulted in new surgeries for more than 11,000 Americans who need the device to shock their hearts back into a normal rhythm once it starts beating irregularly.

    About 46,000 of the $20,000 devices covered in Friday's announcement are in use worldwide, the company said. The Contak Renewal 3 is the company's largest seller, analysts said. Guidant reported $1.8 billion in defibrillator sales for 2004, an 18 percent increase from 2003 and 47 percent of the company's total sales.

    Guidant said doctors "should discontinue implants of these devices pending further notice."

    The company said that it had informed federal regulators of its action and that the Food and Drug Administration may classify it as another recall. FDA spokeswoman Julie Zawisza said the agency was evaluating the company's announcement and that it had not yet been classified as a recall.

    "We support the company notifying the physician community and patients about this latest device issue," she said. "We'll be looking at the information they provided in the coming hours and days to evaluate the situation."

    The five devices included in Friday's announcement have had at least four malfunctions among them, Guidant said.

    A fifth suspected case has not been confirmed, but no patients using the devices have died or been injured, the company said.

    Last week Guidant said two deaths had occurred in patients using the models included in its recall, without specifying the models. It also said the seven devices had had 45 failures among them.

    An implantable defibrillator is intended to sense an irregular heart rhythm and shock the heart back into beating correctly. The device is the size of a small pager.

    The five defibrillator models cited by Guidant Friday have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch can also limit a defibrillator's battery life.

    Guidant said physicians should reprogram the five defibrillator models so that their magnet use is off. The devices will continue to function. Patients who hear tones from the defibrillators, however, should go to the emergency room immediately.

    "Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients," company spokesman Steve Tragash said in a statement. "The actions taken today and over the last several weeks reflect our commitment to expand physician and patient communication."

    "The truth is if this is evidence of anything, it's that things are all upside down at Guidant," said Chris Seeger, a New York attorney who has filed a lawsuit against the company for what he says was its failure to notify patients about safety problems in defibrillator models.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Some heart devices faulty
    Guidant issues safety advisory
    Published: Saturday, June 25, 2005 -- The Truth, A1
    Last updated: 6/24/2005 11:19:15 PM
    By Marilyn Odendahl
    Truth Staff
    Heart patients were given another reason Friday to call their cardiologists.

    Guidant Corp., the Indianapolis-based maker of cardiovascular devices, issued a second safety advisory in a week about its implantable defibrillators.

    However, local health practitioners said patients with these devices have little cause to worry.

    "It's not an emergency," said Lori Woltman, LPN at the Center for Heart Care at Elkhart Clinic. "It's not anything to panic about."

    Not only patients, but investors are concerned, questioning whether Johnson & Johnson will complete its proposed acquisition of Guidant.

    Some of the devices in the advisory are reported to have failed to deliver electrical shock and other devices are reported to have a magnetic switch that may get stuck in the closed position. According to Guidant press releases, of the 109,000 devices under the warning that have been implanted worldwide, 49 have malfunctioned, resulting in two deaths.

    Patients who have Guidant defibrillators are being told to check their cards to see if they have the models under the advisory and then contact their cardiologists.

    "At this point, our office is looking at patients on a case by case basis," said Shelley Fowler, exercise physiologist at Midwest Cardiovascular Specialists in Elkhart.

    She said that so far, Midwest Cardiovascular has not performed any surgeries to replace the devices.

    The U.S. Food and Drug Administration is not making any recommendations about whether the Guidant devices should be replaced or removed. The agency said that decision should be made by the patient and doctor based on the medical situation.

    Dr. Guru Kulkarni, electrophysiologist with Midwest Cardiovascular, said he will allow his patients to determine their course of treatment. "If they want it replaced, I will be happy to replace it because (it) was put in there to save their life," he said. "I will leave it up to the patient."

    Kulkarni explained if the wires or leads connecting the device to the heart are OK, he would only have to change the battery and the patient could go home the same day. "It's not a big deal to change it," he said.

    At Emory University in Atlanta, Dr. Jonathan Langberg, director of cardiac electrophysiology, was preparing to replace a defibrillator of a patient whose model was recalled by Guidant last week. But the model set to be implanted during a Friday morning surgery received a safety warning, too.

    Langberg said his patients received defibrillators from Medtronic, Guidant's leading competitor.

    "The patients I've seen in the clinic are understandably worried about whether their safety net has got holes in it," he said. "The probability that the device will fail is very low. But we're talking about a device that is necessary to keep you alive, so even a relatively small chance of a problem is something that needs to be thought about very carefully."

    The pager-sized devices use an electrical shock to return to normal a heart that is beating abnormally fast or chaotically. With people living longer and therefore more likely to experience a problem with their heart rhythm, these high-tech devices are becoming more common.

    "It's a therapy that's delivered to fix a problem but it's not a cure," said Woltman of defibrillators.

    Guidant, Medtronics and St. Jude are the three companies that make implantable defibrillators. This latest safety advisory from Guidant has analysts wondering about the impact on the planned acquisition by Johnson & Johnson. Guidant shareholders voted in April to accept Johnson & Johnson's offer of $76 per share in cash and stock.

    J&J spokesman Jeffrey J. Leebaw declined to comment on Friday's developments.

    The Associated Press contributed to this story
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

    Comment


    • #3
      Guidant Shares Fall Sharply on New Warning on Heart Device

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      By BARRY MEIER
      Published: June 24, 2005
      The Guidant Corporation, already under scrutiny for delaying disclosures about flawed products, urged doctors today to stop implanting its most sophisticated heart devices because of a fault that might cause some of the 40,000 that have already been implanted to fail.

      The move could have significant financial consequences for Guidant because, for now, it halts company sales in the fast-growing end of the market for heart devices- advanced defibrillators that also act as pacemakers for both sides of the heart.

      The devices at issue accounted for about 20 percent of Guidant's total sales of $3.8 billion. Today, the company's stock fell $4.70, or 6.85 percent, to close at $63.90 as Wall Street investors grew nervous over the fate of Johnson & Johnson's plan to acquire Guidant for $25.4 billion. The merger is not yet complete, although Guidant shareholders approved the deal in April.

      Analysts said they believed that Johnson & Johnson would likely cut the acquisition price and added that the deal's planned closing might be delayed. Both Johnson & Johnson and Guidant had no comment and declined to make their top executives available for interviews.

      In recent weeks, Guidant, which is based in Indianapolis, has been in the public spotlight after the disclosure that it did not tell doctors for three years that one of its defibrillators had repeatedly failed because of an electrical defect. Last Friday, the company, under pressure from federal regulators, recalled tens of thousands of defibrillators because they could short-circuit.

      A defibrillator is a device that emits an electrical jolt intended to shock a chaotically beating heart back into rhythm.

      Today's announcement, however, may have a more immediate financial impact on Guidant because it involved advanced devices that combine a defibrillator and pacemaker for both sides of a patient's heart. As a result, it ends the company's presence, for now, in the fastest-growing market for heart devices.

      "Right now, all we are using are other companies' devices," said Dr. Eric N. Prystowsky, a cardiologist at St. Vincent Hospital in Indianapolis and a top outside medical consultant to Guidant.
      Knowledge is power ... Stay informed!
      YOU can make a difference - all you have to do is try!

      Dx age 12 current age 46 and counting!
      lost: 5 family members to HCM (SCD, Stroke, CHF)
      Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
      Therapy - ICD (implanted 97, 01, 04 and 11, medication
      Currently not obstructed
      Complications - unnecessary pacemaker and stroke (unrelated to each other)

      Comment


      • #4
        Guidant Issues New Warning on Heart Devices

        --------------------------------------------------------------------------------
        By Julie Steenhuysen
        Reuters
        Jun 24, 2005



        CHICAGO - Guidant Corp. Friday advised doctors to stop implanting some of its most sophisticated heart defibrillators, saying the devices may be faulty and may have to be recalled.
        The warning comes one week after the company recalled several earlier versions of its implantable defibrillators- designed to shock irregular heartbeats back to normal rhythms- after they were linked to two deaths and 43 reports of malfunctions.

        Guidant shares tumbled 12 percent in early trading. Analysts said the latest warning puts Guidant's key product line at risk and raises new worries about the company's deal to be acquired by Johnson & Johnson.

        The latest problem involves pacemaker and defibrillator combination devices used to treat patients with heart failure and guard against dangerous heart rhythms.

        "This is a different problem. It's more significant as it affects products they are already selling," said Keay Nakae, an analyst with C.E. Unterberg, Towbin.

        "This is a large chunk of revenues. It could be about 20 percent of corporate revenues (of about $4 billion)," said Susquehanna Financial Group analyst Mark Landy.

        Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs.

        Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.

        Four incidents have been confirmed out of about 46,000 devices; a fifth is suspected but cannot be confirmed, the company said.

        In the four occurrences in which the device was implanted, the device sounded a warning that alerted patients or their physicians to the defect, and the devices were replaced.

        One other incident occurred in a device before it was implanted.

        Guidant said it would establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices.

        It said it would cooperate with and enlist the support of other interested parties, including the U.S. Food and Drug Administration, patient advocates, and physician societies.

        Guidant shares were down $6.59 at $62.01 in late-morning trade on the New York Stock Exchange after falling as low as $60 earlier in the session
        Knowledge is power ... Stay informed!
        YOU can make a difference - all you have to do is try!

        Dx age 12 current age 46 and counting!
        lost: 5 family members to HCM (SCD, Stroke, CHF)
        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
        Therapy - ICD (implanted 97, 01, 04 and 11, medication
        Currently not obstructed
        Complications - unnecessary pacemaker and stroke (unrelated to each other)

        Comment

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