23 May 2023 |
Loma Linda University International Heart Institute has become the first center in the western United States to utilize the Impella ECP heart assist device during high-risk percutaneous coronary intervention (PCI) procedures. The institute’s heart care team is participating in the Impella ECP Pivotal Trial, conducted by the FDA, to evaluate the safety and effectiveness of Abiomed’s percutaneous left ventricular assist device for high-risk PCI procedures.
According to Loma Linda University Health’s website, the Impella ECP device is used to support patients with multivessel coronary artery disease who have risk factors that make them ineligible for open-heart surgery. It behaves as a support pump, assisting the heart function during complex procedures. The device is inserted through the femoral artery in the groin using a catheter and is guided to the heart’s left ventricle. It takes over the heart’s function by pulling blood from the left ventricle and expelling it into the aorta to maintain blood circulation.
The percutaneous left ventricular assist device received FDA breakthrough device designation in August 2021 and is smaller in size compared to previous versions. Institutions participating in the Impella ECP Pivotal Trial aim to determine the benefits of the device’s reduced size, such as lower risk of bleeding complications, stroke, or damage to other arteries.
The smaller size of the device may offer new opportunities for patients who would not have been eligible for a larger percutaneous left ventricular assist device. Loma Linda University, along with its team of cardiologists, has already performed several interventions with the Impella ECP device and continues to enroll eligible patients in the trial. The university is one of nine U.S. institutions participating in the trial and currently the only medical center west of Minnesota using the device in procedures.