Johnson & Johnson MedTech has announced an important milestone: the FDA has extended approval for use of Impella heart pumps in treating certain pediatric patients.
The approval expansion includes the use of the Impella 5.5 with SmartAssist and the Impella CP with SmartAssist. These devices are specifically designed for children dealing with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.
Known for being amongst the smallest heart pumps globally, these devices are set to provide significant benefits to pediatric heart patients.
Johnson & Johnson MedTech collaborated closely with the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) to gather the essential real-world data necessary to endorse the labeled use of these devices.
ACTION is a worldwide healthcare network consisting of patients, their families, clinicians, researchers, and industry partners, all committed to enhancing patient outcomes.
“This achievement represents a vital step forward in pediatric heart failure treatment, traditionally an area that has not received adequate focus or resources,” commented Angela Lorts and David Rosenthal, co-founders of ACTION. “We cherish our partnership with Johnson & Johnson MedTech in achieving this significant approval and look forward to continuing our efforts to improve care for these vulnerable patients.”
The Impella CP and Impella 5.5 heart pumps assist by unloading the heart’s left ventricle, giving it a chance to rest while facilitating the circulation of oxygenated blood throughout the body.
This approval broadens the devices’ application to include specific pediatric patients who are eligible based on weight. The Impella CP is now suitable for children weighing 52 kg (114 lb) or more, and the Impella 5.5 is appropriate for those weighing 30 kg (66 lb) or more.
“We are deeply grateful for the opportunity to assist the hearts of pediatric patients with our life-saving technology,” expressed Sonya Bhavsar, senior director of R&D, ECP and the pediatrics platform in Johnson & Johnson MedTech’s heart recovery division. “This accomplishment encourages us to innovate further and find solutions that will enhance the lifespan and quality of life of our patients, allowing them more time to share with their families and loved ones.”