Boston Scientific
FDA investigates Taxus stent
The FDA said it is investigating problems with Boston Scientific's Taxus stent after a Michigan hospital suspended use of the devices. William Beaumont Hospital in Royal Oak stopped using the stents for a two-week period in late September and early October after a series of problems, The Wall Street Journal reports. In three cases doctors experienced problems removing the wire used to hold the stent in place. Cardiologists at the hospital have since gone back to using …
... Read more...SPOTLIGHT: Higher risk of clots in drug coated stents
New evidence appears to show that there may be long-term risk of blood clots associated with drug coated stents. Researchers presented evidence which shows "a small but real increase in clots" in the 18 months to three years after implantation. The data covers the two leading brands of drug coated stents, Johnson & Johnson's Cypher and Boston Scientific's Taxus. Some experts, like the Cleveland Clinic's Dr. Eric Topol, said the news is a red flag and argue that problem is one …
ALSO NOTED: Boston Scientific posts loss;McLellan calls for 'digital Infosphere';and much more...
> Boston Scientific scored a legal victory in its fight with Johnson & Johnson over the drug eluting stent market when a Dutch court ruled in its favor. Article
> Bad numbers though, for Natick, MA-based Boston Scientific, which reported a loss of $269 million for the third quarter due to declining sales of its Taxus stent and a $598 million legal settlement. …
... Read more...FDA scrutiny led to Guidant recalls
The Wall Street Journal reports that closer FDA scrutiny of Guidant's product lines led to yesterday's recall of its Insignia and Nexus pacemaker models. The paper says the problem was uncovered during last week's FDA inspection of the Guidant plant in St. Paul Minnesota. Initial evidence suggests the defects are non-fatal and have led to only a few hospitalizations.
- see this …
... Read more...ALSO NOTED: Boston Scientific settles stent dispute; Guidant issues yet another recall; Texas Hospitals prepare for Rita; and m
> As Hurricane Rita was upgraded to Cat -5 status, HCA said it will close its Houston area facilities. Story
> Another Merck executive has given testimony damaging to his company's image. Edward Scolnick said his "anxiety quotient" about the drug was very high as early as the year 2000. Story
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... Read more...ALSO NOTED: Pharmacists helping Katrina victims; Stress fights cancer?; and much more...
> The Walgreen pharmacy chain has given up charging Katrina victims for prescriptions in Houston and Louisiana. With the doctor shortage widespread, pharmacists are stepping in to provide a range of healthcare services. Story (Wall Street Journal sub. req.)
> Time to move to New York? A study in the British Medical Journal suggests that stress may actually reduce the chances women …
... Read more...Boston Scientific warns on stent sales; Studies disagree
Boston Scientific warned this morning that sales of its formerly best-selling Taxus stent are likely to fall below expectations, and the company admitted it is unlikely to match its earnings estimates for the third quarter. The news follows directly on the heels of a series of reports on the effectiveness of leading stent brands delivered at this week's meeting of the European Conference of Cardiology. One study, due to be published next week in the Lancet, finds that stents made …
... Read more...Boston Scientific gets FDA rebuke over faulty devices
Boston Scientific is in trouble after regulators discovered last month that the company shipped a number of faulty devices to hospitals. The FDA issued the strongly-worded warning this week after investigators determined that the company shipped the defective devices from its Quincy, Massachusetts, distribution center instead of quarantining them after quality problems were discovered. The specific devices involved include eight Taxus coronary stents, five Vaxcel ports and an unknown …
... Read more...ALSO NOTED: PacifiCare-UnitedHealth merger prompts questions; Misys launches CDHP portal; and much more...
> The impact of UnitedHealth's merger with PacifiCare is examined in the Las Vegas Journal Review. Story
> HIT: Misys announces the launch of a web portal for physicians steering patients to consumer-directed programs. Release
> MedTech: Boston …
... Read more...J&J to increase Cypher production
Johnson & Johnson announced that it will ramp up production at the Puerto Rico facility where its drug-coated stent is manufactured after a series of studies appear to give it the edge against its competitors. J&J executives say the company can only meet about half the demand for the increasingly popular stent. A study in the Journal of the American Medical Association comparing the Cypher with the Taxus, which is manufactured by rival Boston Scientific, found that …
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