The Latest Cardiac and Vascular News
CINCINNATI, Dec. 13, 2024 /PRNewswire/ — In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech’s Impella Support System to include treatment for certain children suffering from heart failure, extending the original…
DANVERS, Mass., Oct. 28, 2024 /PRNewswire/ — Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal trial on patients supported with Impella ECP™, a novel transvalvular axial flow pump with compressible pump architecture….
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces that Impella RP Flex with SmartAssist has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up […]
Analysis of randomized controlled trial data shows non-Caucasian high-risk PCI patients significantly benefit from Impella-support DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces a new program to address healthcare disparities in underserved communities, as new data provides an example of how better access […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps. The FDA’s action is another affirmation that Impella heart pumps are […]
Smaller Sheath Simplifies Access and Improves Ease-of-Use DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement […]
DANVERS, Mass.–(BUSINESS WIRE)–An analysis of more than 2,000 patients from a large U.S. real-world database finds that patients who underwent a non-emergent high-risk PCI with the Impella heart pump (n=1,447) had significantly improved survival, reduced myocardial infarction, reduced cardiogenic shock after PCI […]
BOSTON–(BUSINESS WIRE)–Abiomed (ABMD) announces the result of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan shows a 30-day survival rate of 77% for patients with cardiogenic shock due to myocarditis. This study is an update […]
BOSTON–(BUSINESS WIRE)–Results of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan (n=1,344) show 30-day survival rates of 81% for AMI cardiogenic shock (AMICS) patients. The study is an update to a 2020 interim analysis […]
BOSTON–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) will highlight how Impella heart pumps help heart teams achieve more complete high-risk revascularization and heart recovery in the catheterization lab and operating room at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 Conference, held in Boston from September 16 […]
