Abiomed (Nasdaq:ABMD) announced today that a three-year study in Japan demonstrated positive results for its Impella heart pump.
Danvers, Massachusetts-based Abiomed’s study is an update to 2020 interim analysis. Results were presented at TCT 2022 in Boston.
The investigator-led study evaluated all Impella-supported patients across 109 hospitals in Japan. Of the 1,344 AMI cardiogenic shock (AMICS) patients, 30-day survival rates totaled 81%.
The analysis examined 293 consecutive Impella-supported AMICS patients in the J-PVAD Registry. Results also showed 81% survival at 30 days. Historical cardiogenic shock survival rates without Impella are approximately 50%, Abiomed said in a news release.
“The results of this study demonstrate that when Impella is used and best practices are followed, it is possible to achieve heart recovery and greater than 80% survival rates for patients with AMI cardiogenic shock,” said lead investigator Dr. Junya Ako, an interventional cardiologist and chair of the department of cardiovascular medicine at Kitasato University Hospital in Kanagawa.
Results are consistent with other published investigator-led studies, Abiomed said.
The company develops Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist. All are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
Last week, Abiomed announced that the FDA approved new clinical research into using Impella heart pumps in severe heart attack patients with cardiogenic shock.