Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures.
With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number of co-morbidities with or without depressed ejection fractions, the Danvers, Mass.-based company said.
“This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned down for surgery with severe coronary artery disease. These patients who have often been managed medically in the past may have a new option for treatment,” Dr. Ehtisham Mahmud of UC San Diego’s Sulpizio Cardiovascular Center said in a prepared statement.
“Our patients are increasingly more complex, requiring higher levels of operator skill and protocol driven use of hemodynamic support in the cath lab. These patients often experience improved quality of life and with complete revascularization can have improved ejection fraction following Protected PCI,” Dr. Tony DeMartini of Edward-Elmhurst Health said in a prepared release.
Approval of the system came based off data from an analysis of 229 patients with mild to moderately reduced ejection fraction, with the majority of patients turned down for open heart surgery due to surgical risk factors and the minority simply refused surgery.
“Abiomed would like to thank the physician community, caregivers, employees and regulators involved in the FDA clinical trials and cVAD post market approval studies. Abiomed takes great satisfaction in knowing that our significant investment in clinical research over the last 12 years has helped thousands of patients, identified best practices and expanded our regulatory indications in both high risk PCI and cardiogenic shock,” prez & CEO Michael Minogue said in a press release.
Yesterday, Abiomed said it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy.