Abiomed's Impella 2.5 and CP Heart Pumps Receive Expanded Indication for High-Risk PCI
February 14, 2018—Abiomed, Inc. announced its Impella 2.5 and Impella CP heart pump devices have received expanded US Food and Drug Administration (FDA) premarket approval for use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures.
As noted by the company, this expanded indication broadens the appropriate use of Impella support and eliminates the requirement for depressed ejection fraction (EF) in the presence of severe coronary artery disease (CAD) or complex anatomy (eg, left main, multivessel, or requiring rotational atherectomy).
Under the expanded indication, the Impella 2.5 and Impella CP are indicated for providing temporary (< 6 hours) ventricular support during elective or urgent high-risk PCI performed in hemodynamically stable patients with severe CAD, 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 the 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.
“This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned down for surgery with severe CAD,” said Ehtisham Mahmud, MD, FACC, FSCAI, in the company’s announcement. “These patients who have often been managed medically in the past may have a new option for treatment.” Dr. Mahmud is Division Chief of Cardiovascular Medicine and Director of the Sulpizio Cardiovascular Center at University of Califonia San Diego in La Jolla, California.
Abiomed advised that the data submitted to the FDA in support of this expanded premarket approval indication included an analysis of 229 consecutive patients with mild to moderately reduced EF from the cVAD registry study. In this cohort, the majority of patients were not candidates for open heart surgery due to their surgical risk factors, and the remaining minority refused surgery. On average, these patients were more often women, older, had more lesions treated, were more hypertensive, and presented with higher EF than patients in the cVAD registry cohort with EF < 35% (n = 464).
This comparison demonstrated that high-risk PCI with Impella support was feasible, safe, and achieved favorable outcomes in patients with mild to moderately reduced EF, stated the company.