U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
DANVERS, Mass. Dec. 12, 2024 /PRNewswire/ -- Physicians have a new treatment option for many of the sickest pediatric patients with heart failure and cardiogenic shock. Johnson & Johnson MedTech, the global leader in heart recovery, announced today that the U.S. Food and Drug Administration (FDA) has expanded the indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, granting premarket approval (PMA) for use in specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. A PMA is the highest level of approval granted by the FDA for the safety and efficacy of medical devices. Impella 5.5 and Impella CP enable heart recovery as part of the world's smallest heart pump platform. Johnson & Johnson MedTech (Abiomed, Inc.) has partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide the real-world data necessary to support on-label use of Impella 5.5 and Impella CP, b
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