Heart pumps’ indication expanded to pediatric patients with HF, cardiogenic shock
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Key takeaways:
- Two heart pump systems were approved for the treatment of acute decompensated HF and cardiogenic shock in certain pediatric patients.
- Real-world data are needed to support on-label use.
Johnson & Johnson MedTech announced the FDA has approved an expanded indication and granted premarket approval for its heart pumps to be used to treat pediatric patients with symptomatic acute decompensated HF and cardiogenic shock.
For one of the devices (Impella CP with SmartAssist catheter and automated Impella Controller), the expanded indication now includes the treatment of ongoing cardiogenic shock not responsive to optimal medical and conventional treatment measures in pediatric patients who weigh at least 52 kg, according to a company press release.
The other heart pump (Impella 5.5 with SmartAssist catheter) was expanded for the same treatment but in pediatric patients who weigh 30 kg or more, according to the release.
The company stated it will collaborate with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to gather real-world data to support on-label use of the heart pumps in the pediatric patients population.
“Having cardiac devices specifically labeled for children, along with pediatric-specific education for health care providers, ensures that young patients receive the safest, most effective care tailored to their unique needs,” Angela Lorts, MD, MBA, co-founder of ACTION, told Healio. “The expanded label will improve access to these critical treatments, ultimately saving more lives of children with heart disease.”
The company stated it will work collaboratively with ACTION and a dedicated team to develop training and education programs designed for pediatric patients and their physicians who use the heart pumps.
“This marks a monumental achievement for children with heart failure as, historically, this area of pediatric care has been underfunded and understudied,” Lorts said in the press release. “We are proud to have worked with Johnson & Johnson MedTech on this crucial approval and look forward to further collaborations that will enhance care for these vulnerable patients.”
For more information:
Angela Lorts, MD, MBA, can be reached at info@actionlearningnetwork.org.
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