Pediatric Medical Device Approved by FDA

According to news sources, the U.S Food and Drug Administration (FDA) today approved the EXCOR Pediatric System. This system is a mechanical pulsatile cardiac assistance device used to support the weakened heart of children with heart failure to keep them alive until a donor for a heart transplant can be found. Heart failure is much less common in children than in adults; therefore, finding a suitable donor usually takes more time. This system is designed to keep the child’s cardiac system functioning while a donor heart is being found. Stroke is a potential risk of using this system. The EXCOR Pediatric System was designated as a Humanitarian Use Device by the Office of Orphan Products Development.

As a Los Angeles personal injury lawyer, I’m glad to learn that such a device exists in order to provide children with heart failure a fighting chance. In my time as a personal injury lawyer, I’ve witnessed many advancements in medical technology; and I’m relieved to see that, though a rare occurrence, children with heart failure have benefited from such advancements.

 

FDA Releases Study on Blood Clots

News outlets reported that the US Food and Drug Administration (FDA) is releasing the final report of the FDA-funded study that evaluated the risk of blood clots in women using contraceptive pills containing drospirenone. The preliminary report of the study was already discussed in a previous Drug Safety Communication (DSC). The final result of the study will be discussed in a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.

As a Renton personal injury lawyer, I feel it’s essential to keep up-to-date with the news issued by the FDA in order to help spread their information and, hopefully, aid in preventing avoidable injuries. If you’ve suffered injuries or adverse health effects through the use of a defective medical device or drug, contact a personal injury lawyer experienced in these matters to learn more about your rights and the legal avenues open to you.