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 to 14 days. Impella RP Flex is implanted via the internal jugular (IJ) vein, which […]
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 to Impella heart pumps can improve health equity for non-Caucasian cardiovascular patients. Data from a […]
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 safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic shock, cardiogenic shock in the […]
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 of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer […]
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 and shorter length of stay than matched patients treated with an intra-aortic balloon pump (IABP) […]
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 to a 2020 interim analysis and was announced at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in […]
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 and was presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference taking place in Boston. The 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 to 19. During the conference, physician-researchers will present clinical data demonstrating Impella leads to higher […]
