Dec. 6 – Texas Heart Institute at St. Luke’s Episcopal Hospital recently participated in the FDA-approved PROTECT I patient safety trial for Abiomed’s Impella 2.5 catheter-based heart pump device.
The PROTECT I trial for the Impella 2.5 is the first FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures, according to the Danvers, Mass.-based Abiomed.
“We are pleased to have enrolled four patients in this important safety and feasibility study; more than any other institution in the United States,” said Andrew Civitello, MD principal investigator of the PROTECT I trial at Texas Heart Institute at St. Luke’s Episcopal Hospital.
Abiomed said its Impella 2.5 is a left ventricular assist device (VAD) that is inserted percutaneously in the cardiac catheterization lab, providing patients with up to 2.5 liters of blood flow per minute. The company also said it can currently be used to treat conditions such as acute myocardial infarction, cardiogenic shock and low output syndrome under CE Mark approval in Europe.