International Circuit
Abiomed expands product portfolio with breethe purchase
Abiomed recognizes the need for ECMO therapy for patients in need of oxygenation and has supported approximately 10,000 ECMO plus Impella (ECPella) patients with cardiogenic shock over the past 10 years. In Japan, more than half of Impella patients receive ECPella for hemodynamic and oxygenation support.
Breethe’s product is a first-of-its kind, easy-to-use compact ECMO system with an integrated oxygen concentrator that eliminates the need for bulky oxygen tanks to promote easier patient ambulation. It has a novel design that is intuitive for health care providers to set up, manage, and monitor. Abiomed invested in Breethe in mid-2019. Breethe has applied for 510(k) clearance by the U.S. Food and Drug Administration (FDA).
Breethe’s founder and the Hales Distinguished Professor of Surgery at University of Maryland School of Medicine, Bartley Griffith, M.D., is a renowned leader in multiple areas of adult cardiac surgery including mechanical circulatory support. Dr. Griffith has collaborated with Abiomed for a number of years and served as the principal investigator of RECOVER I. With decades of experience, Dr. Griffith and his team designed the cutting-edge Breethe system to improve patient outcomes, improve quality of life and reduce total cost of care by changing the way oxygenation is delivered.
“Abiomed is the best positioned company to build on the legacy of what we started,” said Dr. Griffith. “I am confident that the addition of Breethe’s technology into Abiomed’s product portfolio will further enhance Abiomed’s ability to improve outcomes for their patients and serve a new patient population.”
This acquisition provides Abiomed with the opportunity to innovate traditional ECMO technology, focusing on patient ambulation and recovery from acute respiratory failure. For many patients in cardiogenic shock, Impella is the optimal technology because it unloads the left ventricle, perfuses end organs and allows the heart to rest and recover. Abiomed recognizes patients in cardiogenic shock may also need oxygenation. ECMO perfuses the end organs but does not unload the left ventricle, which increases the oxygen demand of the myocardium (heart muscle) in these patients. For patients in cardiogenic shock, Impella with ECMO (ECPella) work together to unload the heart and oxygenate the body.
Multiple studies support the association of ECPella therapy to improve outcomes for patients who are suffering from cardiogenic shock and require oxygenation. The European Journal of Heart Failure, ASAIO, and the Journal of the American College of Cardiology have published studies that examine a combined 4,126 patients and conclude use of ECPella was associated with increased survival rates, as compared to patients who were treated with ECMO only. In addition to higher survival, the study in the European Journal of Heart Failure by Pappalardo et al. found higher rates of heart recovery with ECPella use than with ECMO only (62 percent vs. 36 percent; p=0.048).
The Impella 2.5 and Impella CP devices received FDA PMA (pre-market approval) to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with Smart Assist are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP is FDA-approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Impella is the most studied mechanical circulatory support device in the history of the FDA with more than 10 years of FDA studies, real world clinical data on more than 140,000 patients and more than 650 peer-reviewed publications.
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to 5 days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with Smart Assist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia. –MPO