Abiomed’s Impella ECP heart pump, which the company says is fully compatible with small bore access and closure techniques, has been granted the FDA’s breakthrough device designation.
The device, which measures just 3 mm long, is billed by Abiomed as “the world’s smallest heart pump.”
The FDA’s decision was based largely on clinical data from the first 21 patients to receive this device. The very first Impella ECP patient, an 80-year-old Detroit patient with a history of heart disease, returned home two days later, and Abiomed has said he is in good health.
“This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available to more patients who need hemodynamic support for coronary revascularization,” Chuck Simonton, MD, Abiomed’s chief medical officer, said in a prepared statement.
Abiomed emphasized in its announcement that this device is still only to be used for investigational use.
Previous Cardiology Business coverage of the Impella ECP heart pump is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.