J&J Impella Heart Pumps Get Expanded Indications

FDA has approved a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps and their use in specific pediatric patients with symptomatic acute decompensated heart failure and cardiogenic shock.

Johnson & Johnson MedTech (formerly Abiomed) says it partnered with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to provide necessary real-world data necessary to support the expanded use of the left-sided heart pumps. ACTION is described as a global healthcare network of patients, families, clinicians, researchers and industry representatives that collaborate to improve outcomes for patients.

J&J says the heart pumps “unload the heart’s left ventricle, allowing the heart to rest while also ensuring delivery of oxygenated blood throughout the body.” The expanded use is intended for pediatric patients weighing more than 52kg for Impella CP and more than 30kg for Impella 5.5, it adds.