The U.S. FDA has approved the first device intended to treat acute coronary artery perforations. This Stent System provides a new treatment option that can seal a perforation during Percutaneous Coronary Intervention (PCI) in order to stop blood leakage. This device will help in preventing a potentially life-threatening complication or a more invasive surgical procedure.
An acute coronary artery perforation is a rare, but potentially life-threatening complication mostly occurring during PCI procedures. During the procedure, a thin flexible tube with a balloon on the end is inserted into a narrowed coronary artery which expands the artery. The stent is then placed to hold the artery open and increase blood flow to the heart muscle. On very rare occasions, a deep tear occurs in the wall of the treated coronary artery during the procedure, referred to as an acute coronary artery…
