Abiomed (NSDQ:ABMD) today announced that the FDA has granted breakthrough device designation for its Impella ECP expandable percutaneous heart pump.
Danvers, Mass.-based Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the body. It expands in the heart to support the heart’s pumping function and provides a flow greater than 3.5 L/min.
The FDA granted breakthrough device designation based on positive clinical data from the company’s first 21 Impella ECP patients who were treated as part of an FDA-regulated early feasibility study, which was approved in June 2020.
“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,” chief medical officer Chuck Simonton said in a news release.
Abiomed’s breakthrough device designation follows the FDA’s premarket approval of its Impella RP right heart pump in June.
