Abiomed has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump.
Compatible with small bore access and closure techniques, Impella ECP is claimed to be the smallest heart pump in the world.
Upon insertion and removal from the body, the heart pump measures 9 French (3 millimeters) in diameter.
Abiomed’s chief medical officer Chuck Simonton said: “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.”
The FDA breakthrough device designation for the device is in part based on positive clinical data from the first 21 patients treated with Impella ECP.
According to Abiomed, Impella ECP’s size could allow more physicians to offer critical hemodynamic support to coronary artery disease patients who require it.
The company said that there are estimated 440,000 patients indicated and yet undertreated for high-risk percutaneous coronary interventions (PCI).
Abiomed’s FDA approved devices to treat certain advanced heart failure patients undergoing elective and urgent PCI include the Impella 2.5 and Impella CP.
The Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock.
The Danvers, Massachusetts-based Abiomed is engaged in offering medical devices that provide circulatory support and oxygenation.
In June, the company secured the FDA approval for its Impella RP with SmartAssist device to treat acute right heart failure for up to 14 days.
The next generation Impella RP device is claimed to be the first single-access temporary percutaneous ventricular support device with dual-sensor technology.
