Rest for the heart
By Katie Pfaff
Abiomed Inc. was awarded an expanded PMA to treat heart failure linked to cardiomyopathy resulting in cardiogenic shock, adding to the April 2016 indication for acute myocardial infarction (AMI), cardiogenic shock, and post-cardiotomy cardiogenic shock. The expansion is applied to Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, which are temporary ventricular support devices for short use in order to alleviate ventricle strain and provide time for recovery and functional assessment.
"In the setting of cardiomyopathy with cardiogenic shock, the Impella heart pump platform stabilizes the patient's hemodynamics and directly unloads the heart providing blood flow to the body's organs," said George Batsides, chief of cardiac surgery and surgical director of mechanical circulatory support, Hackensack University Medical Center. "The goal of this therapy is to rest the heart muscle, allowing recovery to the patient's baseline function. This treatment is the ideal solution to restore a patient's quality of life, especially for patients older than 65 and not eligible for heart transplant."
The FDA nod for Danvers, Mass.-based Abiomed was based on a 93-patient analysis of its IRB-approved, multicenter, prospective Cvad registry of more than 1,000 data points, reviewed by FDA, and a literature review of 32 publications, which included 109 patients treated with Impella. Earlier FDA studies reinforce safety and efficacy data for Impella for emergency and elective patients. The indication also includes safety analysis as part of the MDR process for the FDA from more than 50,000 patients who received treatment between 2008 and 2017.
"Our ongoing Cvad registry study and IQ commercial database starting from 2008 allows Abiomed to capture real-world evidence on all Impella patients suffering from heart failure associated with hemodynamic instability," said Michael Minogue, president, chairman and CEO, Abiomed. "As we identify best practices, we remain committed to partnering with heart teams to establish protocols to improve patient outcomes and provide cost effective patient care."
The company also will complete a five-year post-approval study based on the registry.
Minimally invasive, catheter-placed Impella systems include Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters, which work in conjunction with the Automated Impella Controller. Less than four days of use is suggested with the 2.5 and CP models, and less than six days of use for the 5.0 and LD. All systems are specified for treatment of patients with continuous cardiogenic shock less than 48 hours after open heart surgery, AMI or cardiomyopathy. The latter may include peripartum cardiomyophathy or myocarditis, which arises from isolated left ventricular failure not mitigated by treatment.
"There is clearly a need to find a solution to treat and improve the quality of life for this population," according to Abiomed. "Real-world data from Abiomed's Cvad registry led the company to seek an expanded indication for cardiomyopathy leading to cardiogenic shock."
The device can stabilize hemodynamics for the patient, maintaining blood flow to vital organs while also providing rest to the heart.
"No other therapy is FDA approved to enable heart recovery. With this new indication, there is now an FDA-approved option that can be used in the cath lab for pregnant mothers and new moms that can enable heart recovery," according to the company.
Patients have otherwise been treated with surgery, heart transplant or inotropic medications, which may ultimately weaken the heart.
Cardiomyopathy is the top cause of hospitalization in patients over 65, and is linked to $20 billion annually in Medicare costs, while myocarditis is more common in younger patients and is often tied to a virus. Myocarditis can result in heart failure, cardiac dysfunction, and 10 percent of sudden deaths in young adult patients. Impella RP recently won approval in September 2017 for patients with acute right failure or decompensation after heart transplant, myocardial infarction, left ventricular device implantation or open heart surgery.
Coming out of the expanded indication, Abiomed also launched an awareness and education initiative, Women's initiative for Heart Recovery, specifically aimed at peripartum and postpartum cardiomyopathy (PPCM) patients. Under the initiative, Abiomed will create a physician and patient advisory board "to make heart recovery the standard of care for women suffering from cardiogenic shock," said Minogue. Heart disease is the top killer of U.S. women over age 20, according to CDC, including PPCM (associated with 10 percent mortality) and spontaneous coronary artery dissection (SCAD).
PPCM is tied to poor outcomes for the infant, and is a leading cause of death of the mother, and is often asymptomatic. SCAD can occur in healthy and young women, and it may cause cardiogenic shock or death.
"The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy," said Cindy Grines, chair, Zucker School of Medicine at Hofstra/Northwell Health. "Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery, for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients."
Earlier this month, Abiomed reported its "best" quarter in Q3, driven in part by Impella's adoption worldwide. The company's valuation jumped to $11 billion from $4.6 billion the prior year. (See BioWorld MedTech, Feb. 5, 2018.)
"Fiscal third quarter revenue increased $39.3 million or 34 percent to $154 million," said Robert Bowen, consultant, Abiomed, during the February earnings call. "U.S. Impella revenue rose 30 percent to $130.7 million, driven by a 33 percent increase in patient utilization. Outside the U.S., Impella revenue totaled $17.3 million and was up 94 percent. Additionally, worldwide service revenue of $6 million was up 25 percent. In the U.S., at the end of the fiscal third quarter, the Impella 2.5 has been placed at 1,181 of approximately 1,400 targeted hospital sites for a penetration rate of 84 percent. Impella CP has been placed at 1,134 hospital sites for a penetration rate of 81 percent. Impella 5.0 has been placed at 498 sites for a penetration rate of 36 percent and Impella RP has been placed at 222 sites for a penetration rate of 16 percent."
Published February 14, 2018