A Detroit resident is the first patient to have been successfully treated with the Impella ECP, the world’s smallest heart pump, developed by Abiomed in Massachusetts.
The patient was treated by Dr. Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan.
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.
At only 3 millimeters, the Impella ECP is designed so that it uses the smallest point when inserted into and removed from a patient, resulting in a less invasive approach to heart recovery. The device then expands in the heart to promote blood flow for patients with heart issues, such as narrowing of the arteries.
“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,” says Kaki. “This new technology allows for a less invasive approach which may ultimately lead to better healing and recovery.”
Dr. Timothy Smith, a cardiologist at The Christ Hospital in Cincinnati, Ohio, performed the second procedure with Impella ECP.
“This groundbreaking technology will help more physicians provide critical hemodynamic support to patients who need it,” says Smith. “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.”
Impella ECP is being studied under a U.S. Food and Drug Administration 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 sheath. It is un-sheathed 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 3 millimiters 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, chairman, president, and CEO of Abiomed.
The primary endpoint of the FDA early feasibility 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 U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.
Impella ECP is an investigational device, limited by federal law to investigational use only.