Release date: 2006-10-25
A major U.S. medical company is taking a closer look at the safety of drug-coated heart stents. Medtronic, the world’s largest medical device manufacturer, has announced plans to conduct a large-scale randomized clinical trial comparing two types of drug-coated coronary stents. This will be the most comprehensive study of its kind to date. The trial involves stents developed by both Medtronic and Johnson & Johnson, and aims to enroll around 8,000 patients across 200 clinics in Europe and other regions. The primary focus of the research is to evaluate the rate of blood clots (thrombosis) following stent implantation.
Dr. Wayne, a Belgian cardiologist and one of the lead researchers on the project, emphasized that no previous large-scale randomized trial had specifically examined the safety profile of drug-coated stents. He noted that this new study will provide a more detailed and long-term assessment of their performance in real-world clinical settings. The data collected could help physicians make better-informed decisions about the risks and benefits of using these stents.
Earlier this year, at the World Heart Congress in September, some experts raised concerns after citing new findings suggesting that patients with drug-coated stents had a higher risk of thrombosis compared to those with traditional bare-metal stents. As a result, the safety of drug-coated stents has once again sparked debate within the medical community. With this new study, Medtronic is stepping up its efforts to address these concerns and contribute valuable insights into the long-term outcomes of this widely used technology.
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