The Impella CP heart pump, which already had FDA approval for use in cardiogenic shock patients, is now indicated for use in high-risk percutaneous coronary interventions.

Abiomed announced its Impella CP heart pump now has FDA approval for a high-risk percutaneous coronary intervention (PCI) indication. The regulatory decision expands the device's approved indications beyond use in patients with cardiogenic shock.

The high-risk PCI indication allows Impella CP to be used for temporary ventricular support (< 6 hours) in "elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction" who have been recommended for a high-risk PCI procedure by a heart team, according to a company press release. 

The device is intended to "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 post-procedural adverse events," according to the release.

Impella CP joins Abiomed's Impella 2.5 in the high-risk PCI indication. Abiomed secured FDA PMA approval of the high-risk PCI indication for its Impella 2.5 device back in March 2015. 

Impella 2.5, Impella CP, as well as the Impella 5.0 and Impella LD, earned the cardiogenic shock label from FDA in April 2016.

Jeffrey Moses, MD, professor of medicine at Columbia University Medical Center, said in the release, "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."

To secure this FDA indication expansion for Impella CP, Abiomed used data from several sources, including a safety study, a randomized controlled trial, a retrospective data analysis, and a postmarket registry.

During Abiomed's October 2016 earnings call, Michael Minogue, president, chairman, and CEO of the company, discussed the underutilization of PCI procedures in high-risk heart failure patients. The expanded FDA indication allows the company to market the Impella CP for this use and train clinicians on the procedure.

"Abiomed is now able to partner with hospitals to expand education and training and to focus on improving outcomes in both high-risk PCI and AMI cardiogenic shock," Minogue pointed out in the press release.

Impella CP is also the subject of an FDA-approved IDE study on its use to unload the heart's left ventricle before a PCI procedure in patients with ST segment elevation myocardial infarction (STEMI) without cardiogenic shock. The feasibility and safety study will enroll up to 50 patients at 10 centers, according to a company release, and should begin in the first half of 2017. 

[Image courtesy of ABIOMED]