Senator Edward M. Kennedy (D-MA), who will take over leadership of the Senate Committee on Health, Education, Labor, and Pensions when the next Congress is sworn in, is not happy with FDA. Today he will make that known at a hearing on potential FDA reform legislation, reports the Boston Globe. Kennedy told the Globe that he believes FDA too often compromises science for politics and is too concerned with pleasing industry. His remarks seemed aimed at drug regulation, but expect any reform plan to impact devices, too, whether directly or indirectly. One potential positive: Kennedy and his fellow Democrats may choose to do something about the Congressional underfunding that has plagued the agency for years.
For years in the treatment of heart attacks, it has been dogma that opening blocked arteries is always a good idea, regardless of when it's done. Now, a large international study has found that performing angioplasty later than three days after a heart attack often does no good, and sometimes causes harm, reports the New York Times and the Associated Press. The study, funded by the National Heart, Lung, and Blood Institute and presented at the American Heart Association meeting, found that patients who underwent angioplasty more than three days after their heart attacks did no better than those who were given the standard drugs to prevent a second attack. It confirmed that angioplasty does help those who have it soon after their heart attacks. These findings could change the...
November 15th, 2006
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German researchers have found that inflating drug-coated balloons inside arteries to medicate blood vessels affected by restenosis may be a more safe and effective method that implanting drug-eluting stents, Bloomberg News reports. The study, published in the New England Journal of Medicine and presented at the American Heart Association meeting yesterday, found that only 5% of patients treated with drug-coated balloons showed excessive scarring afterwards, compared with 43% of patients treated with uncoated balloons. The balloons were coated with paclitaxel and were threaded into reblocked coronary arteries with a bare-metal stent present. The balloons were then expanded and pressed against the vessel wall for one minute to apply the drug. Though about 90% of the drug was washed downstream by blood, it was still a stronger and more evenly-distributed dose than what can be...
November 14th, 2006
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Last week FDA outlined a plan to strengthen its monitoring of medical devices after they hit the market. The report by the Postmarket Transformation Leadership Team lists actions it will be taking to "identify, analyze, and act" on the potential risks of devices. These actions include creating internal performance measures that track how CDRH is handling postmarket issues (such as recalls), revising the system that records reported adverse device events, and increasing the use of the Medical Product Safety Device Network. CDRH Director Dan Schultz called the plan a major step in the direction of providing a postmarket system that, through learning and feedback, ensures the safe and effective use of devices while continuing to encourage innovation.
November 13th, 2006
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While many manufacturers continue to be up in arms about gainsharing, investors have little concern. According to David Blaszczak, senior vice president and healthcare analyst at Stanford Washington Research Group, doctors and hospitals don't seem as interested in the practice anymore. And now that Nancy Johnson (R-CT), one of gainsharings strongest proponents, wasn't reelected, it'll be interesting to see what happens in the coming months. Blaszczak spoke to members of the industry at the Medical Device Manufacturer Association's annual Coverage, Reimbursement, and Health Policy conference yesterday afternoon.
November 10th, 2006
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EP MedSystems Inc. (West Berlin, NJ) said it will pay $244,000 to settle claims by the US Department of Commerce that it shipped products to Iran in 2004 and earlier in violation of trade sanctions, reports the Philadelphia Inquirer. The firm, which makes cardiac monitoring equipment, did not admit or deny any guilt and said it will likely settle with the US Treasury Department as well. It may still face sanctions from the Securities and Exchange Commission and other agencies. It appears the sales happened through a third-party distributor. Yet more reinforcement that you have to be extremely careful about whom you do business with.
November 9th, 2006
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Stories published this morning, including by the Washington Post and
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November 9th, 2006
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The results of a study involving patients who underwent balloon sinuplasty is good news for patients who want a faster recovery, doctors who want to save costs, and manufacturers of the device. The study, noted in the Chicago Tribune, states that patients who had the balloon procedure experienced (in general) faster recovery rates and fewer postoperative doctor visits compared to invasive conventional surgery. Lower healthcare costs ensue, because the technology appears to require less time in the operating room than traditional sinus surgery. The study also found that after six months, most balloon sinuplasty patients were infection-free and had unobstructed sinuses.
November 8th, 2006
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Today's New York Times has an extensive article on the use of electrical stimulation for treatment of migraine headaches. Drug therapy has proven unsatisfactory for many patients, so at least four companies are conducting trials on device-centric approaches. There are two methods being looked at: occipital nerve stimulation and transcranial magnetic stimulation. The former involves a pacemaker-like implant connecting electrodes placed toward the back of the head and delivering stimulation. The latter involves an external device placed on the back of the head that delivers brief pulses. Not surprisingly, the implant solution is being looked at by three big companies (Boston Scientific's Advanced Bionics, St. Jude Medical's Advanced Neuromodulation Systems, and Medtronic) and the external-device solution is being looked at by a small one (Neuralieve of Sunnyvale, CA).
November 7th, 2006
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Thoratec Inc.'s (Pleasanton, CA) heart pump may be part of a cure for congestive heart failure, according to a study published in the New England Journal of Medicine and reported by the Associated Press. A British study found that using Thoratec's pump to power the heart temporarily while administering drugs to shrink its size tripled the usual recovery rate. Late-stage congestive heart failure is normally considered a death sentence, but eight of the 24 patients in the study (which was funded by Thoratec) fully recovered. The procedure must now be confirmed in larger trials before a premarket approval application is filed.
November 6th, 2006
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