What You Need To Know
- Hackensack University Medical Center is enrolling male and female patients between 47 and 80 years of age in the expanded Impella ECP Pivotal Trial, a single-arm, prospective, multi-center trial that evaluates the rate of major adverse cardiovascular and cerebrovascular events (MACCE) in adult patients who receive Impella ECP support during an elective or urgent high-risk PCI procedures.
- An investigational device limited by federal law to investigational use only, Impella ECP is 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands and supports the heart’s pumping function, providing peak flows up to 5 L/min.
- It is the first mechanical circulatory support device to use the EFS pathway as a steppingstone to a U.S. pivotal study.
The Food and Drug Administration (FDA) 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.