The Valley Hospital, Hackensack University Medical Center and Morristown Medical Center enrolled the first New Jersey patients into the trial, expanding enrollment to the second state in the U.S. Up to 256 patients will be enrolled in the pivotal study and receive Impella ECP support during high-risk percutaneous coronary intervention procedures.
The Impella ECP was designed to improve procedural safety and efficacy for patients undergoing coronary revascularization, procedures to restore blood flow to areas of the heart that are not receiving adequate blood supply and require additional blood flow support during their procedure.
Dr. Rajiv Tayal, director of the Cardiac Catheterization Laboratory and Structural Heart Program at the Valley Hospital, and Dr. Hussein Rahim, interventional cardiologist, performed the high-risk PCI cases with Impella ECP support at the Valley Hospital.
“At Valley, we regularly perform high-risk percutaneous coronary intervention procedures on patients who meet the definition of ‘high-risk,’ whether that be due to age, previous medical history or other factors,” Tayal said. “Our participation in this study puts us among the top innovators in the field who are looking to improve patient outcomes for these procedures.”
At Morristown Medical Center, PCI procedures with Impella ECP support were performed by interventional cardiologists Dr. Amir Masoumi and Dr. Dimitrios Karmpaliotis.
Interventional cardiologists Dr. Ankit Patel and Dr. Haroon Faraz performed the Impella ECP cases at Hackensack University Medical Center.
The Food and Drug Administration approved the Impella ECP early feasibility study in June 2020. Impella ECP received an FDA breakthrough device designation in August 2021, demonstrating that Impella ECP meets the FDA’s stringent requirements for a breakthrough device. Impella ECP is the first mechanical circulatory support device to use the EFS pathway as a steppingstone to a U.S. pivotal study.