After the third day of Transcather Cardiovascular Therapeutics show, the results are still mixed regarding the safety of drug coated heart stents. The stents, manufactured by Boston Scientific's Taxus and Johnson & Johnson's Cypher, many experts agreed, there appears to be a long-term clotting risk compared with the use of older bare metal stents. Even some physicians have been reluctant in...
A leading stent manufacturer has admitted that there is an increased clot risk for those with Boston Scientific's cardiac stent. It is the first acknowledgment by a stent maker of an increased risk of the dangerous side effect of stents, which are small wire-mesh tubes used to keep previously clogged arteries open. Drug-coated stents, which are coated with medicine to prevent the growth of...
There was an excellent editorial published in the Palm Beach Postyesterday. The editorial sharply criticizes the docility and unwillingness to monitor Florida doctors. The editorial cites Boynton Beach Dr. Mark Schreiber who was cited by state investigators 3 1/2 years ago yet continues to practice medicine. If public safety is paramount, the Board will start doing its job and discipline...
According to a study published in The Journal of the American Medical Association, malfunctions in implantable cardioverter defibrillators, or ICDs, are on the rise. The device is designed to keep the heart pumping properly and efficiently. Between 1990 and 2002, a total of 2.25 million pacemakers and 415,780 ICDs were implanted in the U.S. Of the implanted pacemakers, 8,834 (4.6 per 1,000)...
In an investigation made public yesterday, officials at Tampa's James A. Haley VA Medical Center disclosed that two cranial implants were not properly sterilized prior to surgery. This is a very serious failure on the part of the hospital and calls into question the basic care patients at the facility are likely to receive. When a patient enters a hospital, especially when facing the...
The first Guidant defective defibrillator trial has been postponed because one of the witnesses is unavailable due to the Passover holiday. The judge has said that the case will most likely resume in July.
An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant's decisions were guided by statistical projections provided by engineers rather than medical data provided by doctors. The group urged Guidant to create an outside panel of...
In a hastily called briefing for Congressional staffers, authorities at the James A. Haley VA Center in Tampa announced that an unsterilized cranial implant was placed into a patient last month. The mistake was nearly duplicated a few weeks later at the same hospital. The hosptial officials waited nearly two weeks before notifying anyone of the error! Of course, the usual political...
According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators, have not been implanted in any patients thus far. Guidant said the FDA may classify the warning as a product recall.
Senate Judiciary Committee Chairman Arlen Specter (R-PA) has introduced legislation that would toughen penalties for companies and their executives who sold products that cause injury or death. Presently, there are only civil penalties for such behavior. In announcing the legislation, Specter singled out Guidant Corp. and their defective defibrillators as an example of actions that would be...
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