On Tuesday, the U.S. Food and Drug Administration approved the use of a HeartWare International heart pumping apparatus for patients that are waiting for a heart transplant.
The ventricular-assist system by HeartWare, which is placed inside the patient, helps pump blood in damaged hearts. The device has already been in the European market.
The U.S. FDA said the benefits that are life saving of the device outweigh any risks seen in studies, which includes possible stroke. The regulatory agency also announced that the system by HeartWare is sufficiently small enough to be implanted inside the chest close to the heart, which allows it to be placed inside adults who are smaller or inside patients who cannot have anything implanted in their abdomen.
Wall Street analysts noted that HeartWare shares were under pressure for the past six week as nervousness from investors over the nearly 24-month wait for FDA approval. The company said it could launch its device immediately in the U.S. Last April an advisory panel to the FDA voted in favor of the device 9-2.
The panel received results of a study that involved over 140 patients who had received the system between 2009 and 2010. The patients were compared to a group of nearly 500 patients who received assist pumps that were commercially available. The study’s results showed over 90% of the patients with the HeartWare device survived for 180 days.
