Abiomed's Impella ECP Granted FDA Breakthrough Device Designation

August 18, 2021—Abiomed announced that the FDA has granted Breakthrough Device designation to the company's Impella ECP expandable percutaneous heart pump.

Impella ECP is 9-F in diameter upon insertion and removal, allowing it to be compatible with small-bore access and closure techniques. In the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min.

According to the company, the FDA granted the Breakthrough Device designation in part based on positive clinical data from the first 21 Impella ECP patients treated in an FDA-regulated early feasibility study. In October 2020, Abiomed announced commencement of enrollment in the study. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols, and premarket approval application. Impella ECP is an investigational device, limited by federal law to investigational use only, cautioned Abiomed.

"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," commented Abiomed’s Chief Medical Officer Chuck Simonton, MD, in the announcement.