Abiomed has announced the treatment of the first two patients using the Impella ECP expandable percutaneous heart pump—a device described by the company as the smallest heart pump in the world. Impella ECP measures 3mm in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5L/min.
The first Impella ECP patient was treated by Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St John Hospital in Detroit, USA. The patient had severe narrowing of his coronary arteries. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP including atherectomy and two one-minute long balloon inflations.
The second patient was treated at The Christ Hospital, Cincinnati, USA by Timothy Smith, an interventional cardiologist and director of cardiovascular intensive care unit, cardiogenic shock and ECMO programs. The patient had severe narrowing of the coronary arteries, including complex left main bifurcation disease and low ejection fraction. Percutaneous coronary intervention (PCI) was successfully performed with support from Impella ECP.
“Ascension St. John Hospital is pleased to be the heart centre leading this patient milestone as part of the early feasibility study of the smallest heart pump in the world,” said Kaki. “This new technology allows for a less invasive approach which may ultimately lead to better healing and recovery.”
“This groundbreaking technology will help more physicians provide critical hemodynamic support to patients who need it,” said Smith. “In the patient we treated, Impella ECP enabled the procedure by providing haemodynamic stability while we treated complex disease in a patient with low ejection fraction.”
Impella ECP is being studied under a US Food and Drug Administration (FDA) early feasibility study. It is designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI. Impella ECP is delivered though a slender profile 9Fr sheath. It is unsheathed in the descending aorta and expands. Then, 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 re-sheathed back down to 9Fr and removed.
“Impella ECP is part of Abiomed’s commitment to continually innovate, patent new breakthroughs, and improve patient outcomes by developing smaller, smarter, and more connected technology,” said Michael R Minogue, Abiomed’s chairman, president and chief executive officer.
The primary endpoint of the FDA early feasibility study is successful delivery, initiation and maintenance of adequate haemodynamic 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 US patients who require revascularisation. If successful, enrolment will be expanded to additional patients, pending FDA approval.
Impella ECP is an investigational device, limited by federal law to investigational use only.