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There has been news on heart stents that has been alarming to patients and physicians. Cordis Corp. received approval for the newest type of stent in April 2003, and news on heart stents traveled quickly, making the Cypher heart stent popular. The news on heart stents indicated the drug coating reduced the possibility of needing another operation.
Successful immediately, Cypher heart stents were quickly distributed throughout the world until in July 2003, the FDA issued news on heart stents. The agency warned it had received updated news on heart stents and informed health care professionals of the "rare but potential risk of thrombosis". Thrombosis, or blood clots, was unforeseen news on heart stents that the bare metal stents were not associated to.
Despite the seemingly negative news on heart stents, the FDA said it needed further review. The news on heart stents did not appear to affect sales of the new drug coated stents and by October 10, 2003, more than 450,000 heart stents had already been distributed worldwide. Just three months after the FDA''s initial news on heart stents, the drug agency issued the second news on heart stents warning.
In July, the FDA had received reports of blood clots in 34 patients, including 5 deaths, but by October the news on heart stents surprised many people. The warning news on heart stents reported the FDA now had over 290 cases of blood clots, including over 60 deaths, as well as more than 50 allergic-type reactions that led to death in some instances. Patients were left with many questions in response to the latest news on heart stents. The American Heart Association considered the FDA''s news on heart stents to be a "red flag."
Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.
The ar...
Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...
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