USA – According to Vascularnews.com, a study indicating severe risks associated with drug-eluting devices has not deterred medical device manufacturers Medtronic and Boston Scientific from supporting the use of these medical products.
The study, published in the Journal of the American Heart Association (JAHA), indicated that the devices caused a sharp increase in the risk of patient death over the two or five years after use. The devices, paclitaxel-coated balloons, and stents are inserted into patients’ blood vessels in their legs.
Konstantinos Katsanos carried out the research and said that the research indicates that more studies should be conducted and that the results the study came to depend on “strong statistical evidence.”
The two companies, whose devices were used analyzed in the research, claim that when they analyze their own data, they cannot find any evidence supporting the higher risk of death.
Katsanos says that while he understands the company’s skepticism of the findings, the numbers indicate too strong of a correlation and that the issue should be investigated.
Representatives of the companies impacted by the findings argue that the study only presents more questions and does not lead to conclusions.
According to the chief medical officer for Boston Scientific, studies such as Katsanos,’ which are based on meta-analysis, often result in findings that later studies do not replicate. He also stated that the study does not indicate any reason that the devices would be causing increased risks of death.
Meredith pointed out that paclitaxel has been used for over 20 years as a chemotherapy agent at doses that far exceed those used in the stents and balloons and that nothing indicates that patients have an increased risk of death when used for this purpose. However, Katsanos argues that the solvent-based paclitaxel has a six-hour half-life while the half-life lasts weeks of months when paclitaxel is used on medical devices.
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