Guidant Medical Device Press Articles

The Indianapolis Star, "Stent slump putting Guidant in play; Johnson & Johnson may make bid, observers say"

          Guidant Corp.'s stent business is like a model strutting down a runway wearing last year's fashions, some industry watchers say.
          Spurned by cardiologists and surgeons once dazzled by its leading-edge heart stents, Guidant has lost business in the past couple of years to competitors whose drug-coated stents can slow artery walls from closing after they are implanted. Now industry watchers say Johnson & Johnson could snap up the Indianapolis company.

Indianapolis Business Journal, "Guidant legal troubles unlikely to affect performance"

          A federal judge recently dismissed one claim against Guidant Corp. over its failed venture with Endovascular Technologies Inc., but much legal wrangling remains on that ill-fated front.
          Indianapolis-based Guidant faces about 40 lawsuits relating to Endovascular and the Ancure Endograft System, a product it made to treat abdominal aortic aneurysms, according to Guidant's latest quarterly report.
          The company also expects more lawsuits to be filed over the product, which also led to criminal charges and a $ 92 million fine in 2003.

The Indianapolis Star, "Guident's turbulent 10-year history"

          2003: Guidant begins designing a human heart model based on computer-aided design technology.
          June 12: Guidant pleads guilty in federal court in San Francisco to violating FDA reporting rules. The company is accused of covering up serious medical problems and deaths associated with the Ancure Endograft System, a device used to treat abdominal aortic aneuryms. On June 16, 2003, Guidant announces it will stop production of Ancure and shut down the manufacturing subsidiary, Endovascular Technologies.

FDA Consumer, "Company caught in coverup of medical device malfunctions; Investigators' Reports"

          When a surgeon couldn't remove part of a medical device stuck in a patient with a serious heart condition, the device maker's sales representative recommended breaking the product's handle -- a procedure that was not approved by the Food and Drug Administration.
          The unapproved handle-breaking technique was just one of the problems uncovered by federal investigators that led to the prosecution of Endovascular Technologies Inc. (EVT) of Menlo Park, Calif. In June 2003, EVT pleaded guilty in U.S. District Court in San Francisco to nine counts of misbranding medical devices and one count of making false statements to the FDA.
          The company agreed to pay $ 92.4 million -- the largest amount ever paid for failing to report medical device malfunctions to the FDA to settle criminal and civil charges. The guilty plea followed a three-year investigation by special agents of the FDA's Office of Criminal Investigations (OCI) and the FBI.