Johnson & Johnson (Abiomed) Announces FDA ExpansionImpella 5.5(With SmartAssist) andImpella CP(With SmartAssist) New Indication, the new indication is for specific pediatric patients with symptomatic acute decompensated heart failure (ADHF) and cardiogenic shock.
"This marks a significant achievement for children with heart failure, as historically, this area of pediatric care has been underfunded and understudied. We are proud to have collaborated with Johnson & Johnson Medical Technologies to obtain this crucial approval, and we look forward to further collaboration to enhance the care for these vulnerable patients."---Angela Lorts ACTION United CreationFounder"The opportunity to treat pediatric patients' hearts with our life-support technology is incredible and fills us with gratitude. This milestone inspires us to continue innovating solutions to increase the number of years these patients can spend with their families and loved ones."---Sonya Bhavsar, Senior Director of R&D for Cardiac Rehabilitation ECP and Pediatric Platforms at Johnson & Johnson Medical TechnologiesSince being acquired by Johnson & Johnson in 2022, the Impella series has become a key product in Johnson & Johnson's cardiovascular field. It is also Johnson & Johnson's cash cow, bringing in significant revenue for the company in 2023 alone.$1.306 billion in sales, achieving a 14.5% growth. Of course, with several billion in sales compared to Johnson & Johnson's $16.6 billion acquisition price, it is still too little. For Johnson & Johnson to recoup its investment, it needs to continue expanding.Sales Volume of Impella Series, According to Johnson & Johnson's Projection Until 2028The sales of the Impella series need to exceed $37 billion. Although there are still four years left, the initial acquisition target cannot be achieved at the current growth rate of just over 10%.For this reason, it is necessary to expandIntended Use of Impella Series and Expansion of Sales Territories. Therefore, Johnson & Johnson continues to expand in the United States.The Impella series aims to expand its intended use to reach more eligible patients and seeks approval for marketing in emerging countries like China, thereby doubling the number of patients treated.
ImpellaIt is an interventional cardiac pump that can be used for cardiogenic shock, left ventricular unloading (in conjunction with ECOM), high-risk PCI treatment, ventricular tachycardia ablation, and right ventricular failure treatment.ImpellaDeveloped based on the principle of the Archimedes screw pump from ancient Greek mathematician Archimedes, the rotation of the impeller can assist in generating forward blood flow, increasing cardiac output, peripheral tissue perfusion, and coronary artery blood flow.
AbiomedDeveloped various types of Impella to meet different flow requirements. Overall,ImpellaThe catheter design is basically similar.
All Impella catheters consist of a miniature Archimedean screw pump mounted on a 9F drive catheter, which is connected to an external controller (AIC).
CurrentlyAbiomedThere are 6 models.Impella Heart PumpApproved for marketing by the FDA.
Previously, Impella 2.5 and Impella CP were suitable for high-risk PCI and cardiogenic shock patients, as well as Impella 5.0.Impella LD andImpella 5.5 is suitable forCardiogenic Shock Patients.Impella RP canProvide right heart support to patients during acute failure.
NowadaysIndications for Use of Impella CP and Impella 5.5Expanded to specific pediatric patients weighing ≥52kg for Impella CP and ≥30kg for Impella 5.5 (Symptomatic Acute Decompensated Heart Failure (ADHF) and Cardiogenic Shock）。
AboveImpellaProducts are allCollectUsing a built-in motor technology route. Johnson & Johnson, in order to maintainIMpella Products Continue to Lead the Integration Industry, has begun to develop the next generation of interventional cardiac pumps --- Adopting the external motor technology route.
Impella ECPYesThe world's smallest hemodynamic support heart pump, itsWith a diameter of only 9 F (3 mm). Despite its small size, it has a considerable flow rate, reaching over 3.5 L/min. Once the sheath is removed, it can expand to approximately 18 Fr.The postoperative removal process is also very simple, requiring onlyRetract the cardiac pump back into the 9Fr protective sheath along the same path.Withdrawal is sufficient.It uses a specially designed pigtail tube and is made from low-durometer polyurethane, thereforePigtail CatheterVery soft, it can guide the heart pump through the aortic valve without injury, just like a guidewire, into the left ventricle.In addition to developing minimally invasive cardiac pumps,AbiomedAlso布局left ventricular heart failure assistance field----Impella BTR(Bridge-to-Recovery) is a device implanted through the axillary artery that can provide a flow rate of 6L/min. It is smaller and less invasive than current LVADs and offers chronic heart failure patients a long-term minimally invasive cardiac pump option.
Abiomed isJohnson & Johnson Medical TechnologiesA part of, the leading provider of medical devices that offer circulatory support and oxygenation. Abiomed's products are designed to rest the heart by improving blood flow and/or providing adequate oxygen to patients with respiratory failure.
