February 14, 2018 — Abiomed Inc. announced it received an expanded U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella 2.5 and Impella CP heart pumps for use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. This expanded indication allows use of the Impella percutaneous ventricular assist pumps to support patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction (EF).
“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 coronary artery disease,” said Ehtisham Mahmud, M.D., FACC, FSCAI, division chief, cardiovascular medicine and director, Sulpizio Cardiovascular Center, UC San Diego. “These patients who have often been managed medically in the past may have a new option for treatment.”
Impella’s initial approval for high-risk PCI was based on two FDA studies (PROTECT I and PROTECT II),[1,2] that treated the sickest and most severe patients in the catheterization lab with the majority being denied open heart surgery. This change broadens the appropriate use of Impella support and eliminates the requirement for depressed ejection fraction in the presence of severe coronary artery disease or complex anatomy (e.g., left main, multi-vessel, or requiring rotational atherectomy). With this expanded approval, the FDA has further validated this first of its kind indication for high-risk PCI and the benefit of percutaneous hemodynamic support in treating severely complex patients with mild, moderate and severely depressed ejection fraction.
Clinical society guidelines from the Society for Cardiovascular Angiography and Interventions, American College of Cardiology, Heart Failure Society of America, Society of Thoracic Surgeons (ACC/HFSA/SCAI/STS) consensus publication support the use of Impella in patients with reduced or normal left ventricular function and severe coronary artery disease for treatment of anticipated technically challenging or prolonged PCI patients.
The Impella 2.5 and Impella CP heart pumps are the only percutaneous temporary ventricular support devices FDA-approved as safe and effective for High Risk PCI, with the new indication stated below:
The Impella 2.5 and Impella CP are indicated for providing temporary (< 6 hours) ventricular support during elective or urgent high risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease, 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 post-procedural adverse events.
Data Supporting Expanded FDA Approval
The data submitted to the FDA in support of this expanded PMA indication included an analysis of 229 consecutive patients with mild to moderately reduced ejection fraction from the cVAD Registry study. In this cohort, the majority of patients were turned down for open heart surgery (CABG) due to their surgical risk factors and remaining minority refused surgery. On average, these patients were older, more often female, had more lesions treated, experienced more hypertension and presented with higher ejection fraction than patients in the CVAD registry cohort with ejection fraction less than 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 ejection fraction.
“Our patients are increasingly more complex, requiring higher levels of operator skill and protocol driven use of hemodynamic support in the cath lab,” said Tony DeMartini, M.D., FACC, interventional cardiologist, Edward-Elmhurst Health. “These patients often experience improved quality of life and with complete revascularization can have improved ejection fraction following Protected PCI.”
The data collection from the cVAD registry includes Institutional Review Board (IRB) approval, complete data monitoring and Clinical Events Committee adjudication. This clinical data reinforces prior FDA studies demonstrating the safety and effectiveness of Impella support in elective, urgent and emergent patient populations.
Watch the VIDEO “Overview of the National Cardiogenic Shock Initiative,” a discussion with William W. O’Neill, M.D., Henry Ford Hospital, Detroit, about the creation of a national initiative to start percutaneous hemodynamic support first before beginning revascularization.
Find out more about recent advances with Impella in the VIDEO “Editor's Choice of the Most Innovative New Technologies at TCT 2017.”
For more information: www.abiomed.com
1. Dixon SR1, Henriques JP, Mauri L, et al. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.
2. William W. O'Neill, Neal S. Kleiman, Jeffrey Moses, et al. A Prospective Randomized Clinical Trial of Hemodynamic Support with Impella 2.5TM versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: the PROTECT II Study. https://doi.org/10.1161/CIRCULATIONAHA.112.098194. Circulation. 2012;CIRCULATIONAHA.112.098194
3. Rihal, C. Naidu, S, et al. 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care. J Am Coll Cardiol. 2015 May 19;65(19):e7-e26. doi: 10.1016/j.jacc.2015.03.036. Epub 2015 Apr 7.