October 28, 2020
First Patients Treated in Feasibility Study of Abiomed’s 9-F Impella ECP Expandable Percutaneous Heart Pump
October 28, 2020—Abiomed announced that the first two patients have been treated with the Impella ECP expandable percutaneous heart pump, which is being studied in an FDA early feasibility study. The Impella ECP measures 9 F in diameter upon insertion and removal from the body. In the heart, the device expands while supporting the heart’s pumping function, providing peak flows > 3.5 L/min.
The first Impella ECP patient was treated by interventional cardiologist Amir Kaki, MD, who is Director of Mechanical Circulatory Support at Ascension St. John Hospital in Detroit, Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP including atherectomy and two balloon inflations of 1-minute durations.
“Ascension St. John Hospital is pleased to be the heart center leading this patient milestone as part of the early feasibility study of the smallest heart pump in the world,” commented Dr. Kaki in Abiomed’s press release. “This new technology allows for a less invasive approach, which may ultimately lead to better healing and recovery.”
The second patient was treated by interventional cardiologist Timothy Smith, MD, at The Christ Hospital in Cincinnati, Ohio, where Dr. Smith is Director of the cardiovascular intensive care unit, cardiogenic shock, and extracorporeal membrane oxygenation programs. The patient had severe narrowing of the coronary arteries, including complex left main bifurcation disease and low ejection fraction. Percutaneous coronary intervention was successfully performed with support from Impella ECP.
In the company’s announcement, Dr. Smith stated, “This groundbreaking technology will help more physicians provide critical hemodynamic support to patients who need it. In the patient we treated, Impella ECP enabled the procedure by providing hemodynamic stability while we treated complex disease in a patient with low ejection fraction.”
According to Abiomed, the Impella ECP is designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI. Impella ECP is delivered through a slender-profile 9-F sheath. It is unsheathed in the descending aorta and expands. Using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the left ventricle. When the procedure is complete, the pump is resheathed back down to 9 F and removed.
On June 5, 2020, Abiomed announced FDA approval of the first-in-human early feasibility study. 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. 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. Currently, Impella ECP is an investigational device and is limited by federal law to investigational use only, advised the company.