June 5, 2020
FDA Approves FIH Trial of Abiomed’s 9-F Impella ECP Heart Pump
June 5, 2020—Abiomed announced FDA approval of the company’s investigational device exemption application to start an early feasibility study through a first-in-human trial of the 9-F Impella ECP expandable cardiac power heart pump.
The Impella ECP is intended for short-term mechanical support in patients undergoing a high-risk percutaneous coronary intervention (PCI) to provide circulatory support and left ventricular unloading. It is currently available for investigational use only and is not approved for use outside of clinical studies.
According to Abiomed, the prospective, multicenter, nonrandomized early feasibility study will allow the company, study investigators, and FDA to make qualitative assessments about the safety and feasibility of Impella ECP use in high-risk patients.
The primary endpoint of the study is successful delivery, initiation, and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. Beginning later in 2020, the study protocol will enroll and treat up to five patients in the United States who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.
Abiomed noted that the Impella ECP achieves peak flows > 3.5 L/min. It is delivered through a slender-profile sheath and unsheathed in the descending aorta, expanding to approximately 18 F. Its design includes a pigtail to cross the aortic valve without a wire and pump from inside the ventricle. When the procedure is complete, the pump is resheathed to 9 F and removed with that same profile.
The device sits across the valve with a soft atraumatic polyurethane cannula that opens only when the pump is flowing. If the pump stops for any reason, this cannula relaxes, allowing the valve leaflets to close around it and maintaining valve competency, stated the company.