Category: Industry Press Releases

FDA Approves Impella 5.0 and Impella LD Extended Duration of Use to 14 Days for Cardiogenic Shock Derived from AMI or Cardiomyopathy

May 15, 2019

DANVERS, Mass.–(BUSINESS WIRE)–May 13, 2019– Abiomed (NASDAQ:ABMD) announces the U.S. FDA has approved the expansion of the Impella 5.0 and Impella LD PMA labeling for the treatment of cardiogenic shock. The expansion extends the duration of support for each pump from 6 days to 14 days. The Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5…

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BD Announces Launch of UltraScore™ 014 Focused Force PTA Balloon

April 25, 2019

FRANKLIN LAKES, N.J., April 1, 2019 – BD (Becton, Dickinson and Company), a leading global medical technology company, announced the launch of the UltraScore™ 014 Focused Force PTA Balloon. This marks the first scoring balloon with sheath compatibility as small as 4 French on the U.S. market.

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Impella RP Post-Approval Study Data Presented at ACC 2019

March 26, 2019

NEW ORLEANS, March 18, 2019 – Abiomed (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies and the maker of the Impella RP heart pump, announces that survival data from the 18 month post-approval study of 42 Impella RP patients was presented at the https://accscientificsession.acc.org/ in New Orleans. The Impella RP is the only percutaneous technology with FDA PMA approval for right…

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Use of Clinical Apps Significantly Improves Quality of Cardiovascular Care

February 27, 2019

A pilot program using several clinical decision support tools in the outpatient setting to treat and educate stable ischemic heart disease patients has shown success in improving angina in these patients. Findings from the Florida Cardiovascular Quality Network study were presented at the American College of Cardiology’s Cardiovascular Summit in Orlando.

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