WASHINGTON, D.C. — The U.S. Food and Drug Administration, according to Medtechdive.com, warned that patients who received paclitaxel-eluting stents and paclitaxel-coated balloons for treatment of peripheral artery disease, or PAD, have a higher mortality rate than recipients of other devices within two years of implantation. The FDA evaluated the result of the study that determined that long term survival after paclitaxel device implantation is not excepted and highlighted the need to study the issue more closely. The FDA pointed to the five medical device manufacturers who produce paclitaxel products to learn more about what is preventing patients from living longer than two years, according to the Journal of College of Cardiology: Cardiovascular Interventions.
PAD is a vascular condition in which plaque builds in the arteries that carry blood to the patient’s legs. Paclitaxel-coated balloons and eluting stents are a relatively new treatment for PAD. The previous treatments would use non-paclitaxel-coated materials essentially to accomplish the same goal, that is, widen the patient’s arteries so that blood can flow to the patient’s legs. Paclitaxel-coated medical devices work to prevent narrowing of the artery again once it has been opened by angioplasty.
Medtechdive.com also reported that paclitaxel-coated angioplasty products are highly beneficial to patients. Experts say these devices have the ability to prevent leg amputation due to PAD. While recognizing the possible benefits of paclitaxel-coated products, the FDA said that more must be done to determine why so many people are dying in such a short amount of time after they have the procedures in which the paclitaxel-coated medical devices were used.
The FDA did take a bold step despite its recognition of the potential benefit of paclitaxel-coated products. The FDA cautioned medical device makers to include warnings about mortality on product labels to draw attention physicians’ attention to the possibility of dying within two years of receiving the medical devices coated with paclitaxel.
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