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The Cypher heart stent manufactured by Johnson & Johnson subsidiary Cordis Corp. entered the market in April 2003. Believed to be a major advance for angioplasty and balloon procedure patients, the Cypher heart stent displayed it could dramatically reduce the risk of blockage recurrence during pre-approval studies. When the Cypher heart stent was FDA approved, the highly anticipated drug coated stent was an immediate success.
The Cypher heart stent coats the wire mesh tube with a thin polymer containing the drug sirolium. Prior to the introduction of the Cypher heart stent, stents were only available in the bare metal form. By releasing the drug coating, the Cypher heart stent is intended to reduce repeat blockage formation.
In July 2003, the FDA issued a warning regarding the Cypher heart stent, cautioning of the possible risk of blood clots among Cypher heart stent recipients. At the time of the warning, the FDA had received reports of blood clots in 34 Cypher heart stent recipients, with 5 deaths resulting. The Cypher heart stent warning failed to slow down distribution of the Cypher heart stents and the blood clot link was considered to be just a "rare but potential risk".
By October 10, 2003, over 450,000 Cypher heart stents had been distributed worldwide. Then on October 29, 2003, the FDA issued a second Cypher heart stent warning. The agency''s Medical Device Reporting system, which is estimated to receive only a small fraction of the actual adverse events, announced it had reports of over 290 blood clots linked to Cypher heart stents. Of the 290 Cypher heart stent blood clots, over 60 people died.
Cardiologists consider the Cypher heart stent to be a breakthrough, though the FDA cardiology devices chief thinks there is a "strong enough signal that as a responsible public heath organization we need to at least inform people" of the possible increased risk of blood clots linked to Cypher heart stents.
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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