Abiomed has announced that its Impella ECP heart pump has completed the first stage in its US Food and Drug Administration (FDA) early feasibility study (EFS), as well as receiving 510(k) clearance for the Impella XR sheath.
The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during Impella delivery then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths.
The Impella XR sheath has been studied in patients outside of the United States on multiple occasions. The first patient in the USA is expected during Q4 of fiscal year 2021.
Additionally, Abiomed has successfully completed the first stage of the EFS of Impella ECP by enrolling and treating five patients. Impella ECP is the world’s smallest heart pump. It measures 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands to support the heart’s pumping function, providing peak flows greater than 3.5 L/min.
The prospective, multicentre, non-randomised EFS is designed to allow Abiomed, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of Impella ECP use in high-risk percutaneous coronary intervention (PCI) patients. Abiomed will now submit data to the FDA and request to move to a second stage of the study with expanded enrolment.
“These milestones are important steps toward the fulfillment of Abiomed’s vision of creating an innovative portfolio of products that are smaller, smarter and more connected,” said Chuck Simonton, Abiomed’s chief medical officer. “Design innovations like Impella ECP and Impella XR sheath will allow for a smaller access site with Impella, which will continue to drive better patient care and outcomes.”