defibrillators

A group of already-vulnerable patients are facing yet another trauma as a wave of implantable heart device recalls hits the market. According Newsday, the FDA has targeted more than 300,000 such devices within the past 18 months alone, the majority of which came from Boston Scientific's Guidant. In some cases, it won't be necessary for doctors to remove the device, but others must go through additional surgery and risk to get the implant out of their body. Generally speaking, …

CMS will phase its new Medicare cost-weighting system in over three years, rather than trying to do it all in 2007 as previously planned. The final regulations, released yesterday, also won't slash payments as deeply as feared when CMS released its initial proposal in April. Only 2 percent of hospitals will have their payments drop, and those drops aren't related to the new rules, says today's story in The Wall Street Journal. Overall CMS payments to hospitals will increase 3.5 …

Look out! If and when Medicare changes come, your institution may be hit hard.  That's the conclusion drawn by many providers, who fear that the proposed reimbursement changes will prove to be far more than a "shift" in funds. Theoretically, providers as a group won't actually lose money. The plan would simply reallocate the $125 billion a year that Medicare pays to hospitals and attempt to cut out biases and distortions that make some patients profitable and others not. But there's …

Boston Scientific said it will recall one of its pacemaker models after an FDA report released last week suggested many of the units will eventually malfunction. The device maker's shares fell seven percent on the news Monday and are down midday Tuesday. CEO Jim Tobin said in a conference call that it may take 18 months to two years to correct problems with the pacemakers and defibrillator lines the company acquired in the Guidant deal this year. He also hinted the recall may not be the …

The New York Times reports that Guidant officials prepared a letter to doctors warning of serious quality control issues with some of its implanted devices long before the company admitted problems, but never sent it. Earlier this week, a Texas court made public a number of company documents, including the letter, which was dated January 2005. The development appears to suggest that liability for Guidant--and new owner Boston Scientific--over the recall of the Contak …

A new study in the Journal of the American Medical Association concludes that patients who have surgery to replace potentially faulty defibrillators recalled by Guidant and Medtronic last year may actually be at more risk than those who leave them in. Researchers looked at data on so-called "explant" surgeries at Canadian hospitals after the recalls and found that 5.9 percent of patients developed complications considered "serious." Three patients died. In contrast, the risk of …

CMS is considering reducing Medicare reimbursements for implantable heart devices, a change that could be a painful hit for specialty hospitals and device makers, if it does in fact go through. The cuts would impact some of the most lucrative heart device categories on the market, including pacemakers, defibrillators and stents. CMS officials say the changes are necessary to eliminate loopholes that specialty hospitals had been exploiting. The agency is weighing reducing payments for …

The FDA said it will set up a team of outside medical experts to study the safety of heart devices currently on the market. The decision is a step in a new direction for the agency, which has historically relied on internal advisory panels to review the safety of drugs and medical devices. The announcement comes days before the release of a report by the Heart Rhythm Society, an influential cardiologists group, which is expected to recommend major changes in the way safety issues are …

Medicare will pay for a potentially revolutionary test that will allow doctors to determine if patients will benefit from a defibrillator. Supporters say the non- invasive test, which measures heartbeat fluctuations, could lead to major changes in the market for cardiac rhythm management devices. Some analysts think the test could dampen the defibrillator market by eliminating people who don't really need the devices. Companies like Guidant, Boston Scientific and Medtronic, which have …

An independent review panel sharply criticized Guidant for its past handling of patient-safety issues. The panel said the company's response to evidence of serious defects involving its pacemakers and defibrillators was inappropriate. Guidant executives learned of the problems three years ago, but chose not to release the information. The group's report finds the company relied on engineers to make decisions about the release of safety information rather than turning to medical experts. …