Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.
The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company.
“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of circulatory support research and clinical applications. This FDA approval marks a significant milestone in the treatment of heart disease. The new medical field of heart muscle recovery has begun. Today, Abiomed only treats around 5% of this AMI cardiogenic shock patient population, which suffers one of the highest mortality risks of any patient in the heart hospital. Tomorrow, Abiomed will be able to educate and directly partner with our customers and establish appropriate protocols to improve the patient outcomes focused on native heart recovery,” CEO Michael Minogue said in prepared remarks.
The company claims the Impella line are now the 1st percutaneous temporary ventricular support devices FDA cleared for treating cardiogenic shock. The devices are indicated for short term use, of less than 4 days for the Impella 2.5 and CP models and less than 6 days for the Impella 5.0 and LD models.
Abiomed said product labeling will also allow for the device to be left in place beyond the 4-6 day duration if a clinical decision is made to adjust for unforseen circumstances.
“This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk. The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function,” Dr. William O’Neill, of the Henry Ford Hospital said in a prepared statement.
The approval adds to the Impella 2.5’s indication for high risk percutaneous coronary intervention which it won in March last year.
In March, Abiomed said it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels.
Abiomed said the federal safety watchdog agreed on the indication for treating patients in cardiogenic shock after a heart attack or cardiac surgery with its Impella 2.5, Impella CP, Impella 5.0 and Impella LD devices.
The company said it submitted data from its 415-patient Recover 1 study, a review of data from another 692 patients in 17 trials, and a safety analysis of more than 24,000 patients using the FDA’s medical device reporting database.