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FDA Expresses Concern over Proposed Second Use of Heart Regulation Device

Our Chicago personal injury lawyers read with concern the FDA’s latest report concerning the fact that regulators aren’t yet certain that AtriCure Inc.’s alternative to open-heart surgery to treat an irregular heartbeat, meets current safety standards.

According to Bloomberg Online, AtriCure’s device has already been approved by the FDA to destroy heart tissue during surgery, but now AtriCure Inc. is hoping to expand the use of the device to block electrical signals and restore a regular heartbeat – this would allow the device to be used as an alternative to a pacemaker or regulation device.

Allowing this use of the device would allow the corporation to market their product as an irregular heartbeat treatment would increase the value of the company’s stock. According to Bloomberg Online AtriCure made $59 million in revenue last year, and if allowed to market their product with a second use, revenue could potentially reach $79 million for 2012.

Nevertheless, the FDA report stated that there have been a number of deaths related to AtriCure’s device. The Wall Street Journal reports that that the FDA’s initial study of AtriCure’s device seems to have been a success, the FDA said that when considering nonsymptomatic patients, “neither the primary safety nor effectiveness endpoints are met, although the results are close.”

The FDA has sought advice from an outside advisory panel, and last week held a hearing as to whether AtriCure studied its device system in an appropriate variety of patients before submitting it for approval to the FDA. The FDA has expressed concerns on whether the device could work to treat every type of atrial fibrillation, and whether if approved, it would be appropriate for use in a wide variety of patients. The FDA isn’t bound by the recommendations of its advisory panels but generally follows their recommendations.

AtriCure filed for approval of the second use of the device in February of 2011, and this past March received a letter from the FDA questioning whether the first study had appropriate criteria in evaluating the effectiveness of the device. AtriCure has proposed that a second study be conducted to evaluate the product.

Products liability law is an area of Chicago personal injury law that focuses on dangerous and defective products. Our attorneys represent plaintiffs across Illinois in matters against corporations or manufacturers who have sold or manufactured unsafe products to consumers. “Products” in this instance cover a wide range of categories, including medical devices. If AtriCure’s product is used to treat patients, and its secondary usage is inadequate in assisting in remedying ailments, the company who manufactures and disseminates the product to the public – in this case AtriCure, Inc. – may be liable for injuries that occur as a result of the use of that device.

Our Chicago personal injury lawyers have handled numerous cases of products liability, and have been successful in their pursuits of justice. In fact, our attorneys won a $3 million settlement against a car manufacturer of a vehicle that improperly designed the fuel delivery system of a vehicle, resulting in a fuel-fed fire after a head-on collision which killed the occupants of the vehicle, and are currently handling a case against Johnson & Johnson regarding flawed orthotic hip replacements.

If you or a loved one has suffered because of a faulty product, contact an attorney immediately to better understand your rights under the law.