FDA Skeptical Though Heart Device Meets Goals

"Meyerkord and Meyerkord, LLC: A Legacy of Legal Innovations"

AtriCare Inc. created a device that is meant to help treat atrial fibrillation. Atrial fibrillation (A-fib) is "a condition in which the upper two chambers of the heart don't pump blood properly". People with this condition are at greater risk of having a stroke. The ablation device passed the main study safety goals, but the FDA is concerned about the use of the device in nonsymptomatic patients, they stated, "neither the primary safety nor the effectiveness endpoints are met, although the results are close". AtriCare Inc. recently settled claims against the company for $3.8 million with the Justice Department. The claims were based on illegal promotion of their ablation systems for A-fib treatment. The ablation devices from AtriCure and other companies have been used to treat A-fib, but have not been specifically approved for that use.

Drug and medical device safety is at the forefront to our minds when it comes to treating medical conditions. The experienced Missouri product liability attorneys at Meyerkord and Meyerkord, LLC will fight for you if it is discovered that you have taken an unsafe medicine and have suffered serious side effects. Contact our knowledgeable family of attorneys at (314) 436-9958 or (800) 391-4318 if you have suffered from a loss due to the negligence of a manufacturer of consumer products such as a medical device that are later found to be unsafe.

**The choice of a lawyer is an important decision and should not be based solely upon advertisements.**

**Past results do not serve as a guarantee of future results.**

**The information on this St. Louis personal injury website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation. This information is not intended to create, and receipt or viewing does not constitute, an attorney-client relationship.**