FDA Grants J&J MedTech a Pre-Market Approval for Innovative Heart Pump

Physicians now have a new treatment option for critically ill pediatric patients with heart failure and cardiogenic shock. Johnson & Johnson MedTech, a global leader in heart recovery, announced 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. The devices have received premarket approval (PMA) for use in select pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock. A PMA represents the FDA's highest level of approval, confirming the safety and efficacy of medical devices.

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