Category: Industry Press Releases

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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Edwards Receives Clearance For HemoSphere Platform With Intelligent Decision-Support Tools

December 29, 2018

IRVINE, Calif., Dec. 3, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that the HemoSphere advanced hemodynamic monitoring platform has received U.S. Food and Drug Administration clearance for the Acumen suite of intelligent decision-support solutions.

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Medtronic receives FDA approval for Valiant Navion­­­™ thoracic stent graft system

November 30, 2018

Medtronic announced in October that it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion™ thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).

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Abbott’s HeartMate 3 heart pump now FDA approved for advanced heart failure patients not eligible for a heart transplant.

November 29, 2018

Abbott announced that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.

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