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cardiologists

Panel critical of device maker; Medtronic may release data

Following a day long meeting of leading cardiologists in Washington sponsored by the Heart Rhythm Society, Medtronic announced that it is considering making public the performance data on its defibrillators. No other major announcements came out of the meeting, but insiders say reporting rules changes are likely given concerns about the recent increase in defibrillator defects. A government study released at the conference found that the number of problems has risen sharply over the last …

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FDA releases new defibrillator safety data

The Food and Drug Administration is expected to release new data this morning which shows that the number of problems with defibrillators rose sharply between 1992 and 2002. According to the FDA, pacemakers have shown an improvement over the same time frame, with the number of problems reported showing a decline. Between 1990 and 2002, the agency said 62 people died as a result of the failure either pacemakers or defibrillator failure.  

Some observers are pointing at …

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Study: Drugs as good as stents for small heart attacks

Another study on stents is likely to stir debate among cardiologists, hospitals, and payers. This one, carried out by Dutch researchers, questions the prevailing wisdom that aggressive intervention using drug eluting stents is a better option for patients who suffered minor heart attacks than waiting for drugs to do their work. The researchers found no difference in outcomes for patients who had stents inserted compared to using a variety of drugs, but suggested that cost would be the …

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Lawmakers want more data on heart devices

On Wednesday, Sen. Charles Grassley (R-Iowa) and Rep. Edward Markey (D-Mass.) said they will call for new rules requiring the FDA to collect more data on defibrillators and pacemakers. Critics have charged that not enough information is gathered from manufacturers, making it difficult for regulators to reliably assess the risks involved with specific models. Health plans and other providers have argued for a long time that they need access to the information in order to better compare …

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Boston Scientific losing this round in stent war?

Cardiologists appear to be moving away from Boston Scientific's Taxus stent in favor of the rival Cypher, a model manufactured by Johnson & Johnson. According to The Wall Street Journal, SG Cowen & Co. analyst Dhulsini de Zoysa wrote in a recent report that the Taxus suffered "dramatic share erosion -- falling to 53 percent of the market" from its previously dominant position, after a recent study linked the stent to a slightly elevated risk of blood clots. That …

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Guidant releases another defibrillator warning

Shares in device maker Guidant stumbled slightly this morning as Wall Street heard that the medical device manufacturer had reported new problems affecting its popular defibrillator lines. The company is warning cardiologists that a design flaw, which it describes as "a possible degradation in the hermetic sealing component," may cause serious health risks to patients who have the devices. Some analysts think the news could put "additional pressure" on Johnson & Johnson's plans …

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ALSO NOTED: HIPAA requirements at hospitals; Defibrillator guidelines prepared; and much more...

> A medical society representing cardiologists who implant defibrillators in patients said it is preparing guidelines for device makers after Guidant's problems. Story (Wall Street Journal sub. req.)

> Investor's Business Daily looks at the IT changes hospitals are being forced to make to meet HIPAA requirements. …

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Angioplasty study challenges 12-hour window

A study released in today's Journal of the American Medical Association challenges the orthodoxy among cardiologists that angioplasties should only be performed with 12 hours of a heart attack. The limited study suggests that patients who get the procedure within 48 hours may suffer less muscle damage to the heart. According to one estimate, up to 40 percent of heart attack sufferers seek treatment outside the 12-hour window. Experts called the finding intriguing, but said more …

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Cardiologists avoid angioplasties in risky cases

New research seems to offer evidence that physicians avoid riskier procedures when data on their performance is made public. A study released today in the Journal of the American College of Cardiology found that cardiologists in Michigan, a state with no reporting law, are far more likely to perform angioplasties on high-risk patients than their counterparts in New York, a state where reporting has been required for a decade. The mortality rate in Michigan was approximately twice …

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Cleveland Clinic to suspend Natrecor

Cardiologists at the Cleveland Clinic have voted to "either ban or severely curtail" use of the heart drug Natrecor after two recently published studies showed it involves serious risks. A panel will vote today to decide if the ban should be a full one. Natrecor is manufactured by Johnson & Johnson. The news is likely to lead to similar actions at cardiology departments across the country. Johnson & Johnson had argued the drug should remain on the market, and had proposed labeling …

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