FDA Approval

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FDA Approval of Drug Eluting Stents, Blood Clot Thrombosis, and Plavix

In late April 2003, the FDA approved the first drug-coated stent for general use by U.S. cardiologists. The drug eluting stent was expected to significantly improve clinical outcomes. While15 percent of bare metal stent patients require another procedure within a year due to restenosis or scarring at the site of intervention that re-impairs blood flow; major Drug Coated Stent clinical trials have demonstrated the ability to reduce restenosis rates to 5 percent or less.

FDA Statement on Coronary Drug-Eluting Stents
FDA is providing the following information in response to inquiries about their position on adverse events related to coronary drug-coated stents. This information describes their position at this time and does not represent new agency policy:

FDA has been closely monitoring Drug Coated Stents since they came into the United States market in 2003 and 2004 – and will continue to monitor them.

The FDA is aware of recent data suggesting a small but significant increase in the rate of death and heart attack possibly due to stent thrombosis (a blood clot in the stent) in patients treated with Drug Coated Stents.

The specific studies that have prompted recent media inquiries are the BASKET-LATE study (presented at the March 2006 American College of Cardiology Scientific Sessions in Atlanta, Ga.) and more recently, the Camenzind meta-analysis (presented at the September 2006 European Society of Cardiology Annual Meeting/World Congress of Cardiology Meeting in Barcelona, Spain). The small but significant increase in the rate of death and heart attacks were observed in these studies and noted in patients following 18 months to 3 years after stent implantation.

The studies presented at the Atlanta and Barcelona meetings have raised important questions yet the data that the FDA currently has does not allow to fully characterize the mechanism, risks, and incidence of Drug Coated Stents thrombosis. A more formal evaluation of the data in these studies is necessary, and any conclusions are dependent upon a thorough peer review. FDA intends to more formally evaluate the studies presented in Atlanta and Barcelona.

Stent thrombosis in patients who receive Drug Coated Stents is a primary area of interest for the FDA because of the potential for serious adverse outcomes—even though stent thrombosis occurs at low rates. Over the past two months, the FDA has met with the manufacturers of the FDA-approved Drug Coated Stents to discuss any information and perspectives they have that may be pertinent. In assessing the risk of stent thrombosis, the FDA is interested in the long-term follow-up of patients enrolled in the original pivotal Drug Coated Stents randomized trials as well as those in the more complex patient and lesion subsets which include patients with diabetes; acute heart attacks or multiple vessel disease; or lesions involving arterial bifurcations, the left main coronary artery, and long arterial segments) who are currently being treated in randomized and registry studies.

FDA also continues to closely evaluate information related to the duration of treatment with clopidogrel (Plavix), a drug used in combination with aspirin to reduce/prevent clotting in Drug Coated Stent patients. Although the duration of Plavix appeared to be adequate for the selected patients in the original clinical trials conducted to support FDA approval, the agency recognizes that the optimal duration of Plavix in more complex patients has not been defined. The recommended Plavix duration of and patient compliance with the prescribed regimen are likely interrelated and associated with Drug Coated Stents thrombosis.

FDA will convene a public meeting of the Circulatory System Devices Advisory Panel by the end of the 2006 in an effort to improve our knowledge regarding the incidence and timing of stent thrombosis as well as the appropriate duration of Plavix use in patients who receive DES.

At this time, FDA believes that coronary Drug Coated Stents remains safe and effective when used in patients having clinical and coronary anatomic features similar to those treated in the pivotal trials conducted by the manufacturers for FDA approval.

Do you have a Drug Eluting Stent Lawsuit?

You or your loved one has suffered a blood clot, heart attack, or death from a drug eluting stent. What was purportedly a medical miracle is now a medical nightmare. Who do you blame? How can you fight back? What can you do about it?

Product negligence and personal injury should not be ignored. There is no cost involved. Start by filling out a short pre-case inquiry form to see if you qualify for a Drug Coated Stent injury lawsuit. Anapol Schwartz Drug Eluting Stent lawyers are standing by.

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DRUG ELUTING STENTS LAWSUIT INFORMATION

When did you have your coronary angioplasty?

Was a stent used?

Yes
No

If yes, do you know what type of stent?

Manufacturer:

Model/Type:

Did the stent contain drugs (drug coated stent, drug eluting stent)?

Yes, the stent contained drugs
No, the stent did not contain drugs

I don't know if the stent contained drugs

What kind of injury did the stent cause?

Coronary artery bypass surgery
Death

Other

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