FDA Approves Abiomed's Impella 2.5 for Elective and Urgent High-Risk PCI

March 23, 2015—Abiomed, Inc. announced that it has received US Food and Drug Administration (FDA) premarket approval (PMA) for the Impella 2.5 hemodynamic heart pump for use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. Impella 2.5 approval is supported by extensive clinical data demonstrating the device’s safety and effectiveness for this complex patient population, stated the company.

The company advised that the Impella 2.5 first received FDA 510(k) clearance in 2008 and has been reimbursed by the Centers for Medicare & Medicaid Services under ICD-9-CM code 37.68 since 2008 for multiple indications, including high-risk PCI.

According to Abiomed, the Impella 2.5 is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk 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 that high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events, stated the company.

The product labeling allows for the clinical decision to leave Impella 2.5 in place beyond the intended duration of ≤ 6 hours due to unforeseen circumstances, noted Abiomed.

William O'Neill, MD, of Henry Ford Hospital in Detroit, Michigan, commented in the company’s press release, “The rigorous data from FDA clinical trials such as PROTECT I and PROTECT II demonstrate that complex, high-risk patients undergoing protected PCI with Impella 2.5 support experience reduced adverse events, improved quality of life and are able to return home faster with fewer repeat procedures. The heart team approach has evolved into a mainstream practice recognized by the guidelines for determining the need for PCI versus surgery and will continue to act as a platform for the screening and determination of the appropriate revascularization treatment for this high-risk patient population."

In addition to the United States clinical trial data, the Impella 2.5 PMA submission included clinical and scientific supporting evidence from more than 215 publications, totaling 1,638 Impella 2.5 patients, and incorporated a medical device reporting analysis from 13,981 Impella 2.5 patients. Data were submitted from PROTECT I and PROTECT II, as well as from 637 high-risk patients enrolled in the United States Impella registry. The registry is an ongoing multicenter, observational retrospective registry including 49 centers. The data collection from the registry includes institutional review board approval, complete data monitoring, and clinical events committee adjudication. Additionally, the PMA analysis included hemodynamic science described in the literature and validated with a series of preclinical and clinical studies.