Abiomed Impella CP Receives Expanded FDA Approval for High-Risk PCI Procedures

December 7, 2016—Abiomed, Inc. announced it has received expanded US Food and Drug Administration (FDA) premarket approval for Impella heart pump use in high-risk percutaneous coronary interventions (PCI) to include the Impella CP treatment option with the ability to stabilize the patient's hemodynamics and unload the left ventricle of the heart, which allows the muscle to rest and recover its native function.

The Impella CP's indication for FDA approval for high-risk PCI is identical to Impella 2.5, and is stated as follows:

"The Impella 2.5 and Impella CP are temporary (≤ 6 hours) ventricular support systems indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events."

In the company's announcement, Jeffrey W. Moses, MD, commented, "This latest approval for Impella expands the hemodynamic options for the cardiovascular community to effectively revascularize severely ill patients who have limited options and high mortality risk. Backed by clinical data and real world experience since 2008, interventional cardiologists working with their heart teams to identify complex PCI candidates can perform complete revascularization on previously untreatable patients to improve their quality of life and their native heart function." Dr. Moses is Professor of Medicine at Columbia University Medical Center in New York, New York.

In April 2016, the Impella CP received FDA approval for up to 4 days of use to treat patients with cardiogenic shock.