Shares of heart pump company Abiomed (NSDQ:ABMD) recovered a bit today — a day after the company’s stock took a 20% dive after two critical studies came out of American Heart Association’s Scientific Sessions.
The two separate studies — one led by researchers in St. Louis, the other out of San Francisco — suggested potentially serious complications involving the company’s Impella heart pumps. Abiomed officials today argued that the research was flawed for three reasons:
- The data source had significant limitations, according to Abiomed. For example, it contained just a fraction of Impella patients and was unable to delineate between common adverse events.
- The Impella patients in the research were much sicker and had greater baseline and procedural risks.
- The analysis excluded the costliest intra-aortic balloon pump patients who were escalated to other therapies.
Abiomed shares were up 3.51% today, closing at $184.34 apiece.
The company noted that physicians have studied Impella for more than a decade — their work including FDA randomized controlled trials, FDA pre- and post-market studies and physician-led initiatives including the National Cardiogenic Shock Initiative (NCSI) study, the INOVA study and the Cardiogenic Shock Working Group.
“The real-world, contemporary experience of the National Cardiogenic Shock Initiative prospective clinical study consistently demonstrates improvements in survival and native heart recovery with best practices that include use of Impella,” Dr. William O’Neill, the principal investigator of NCSI and the medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, said in an Abiomed news release.
“Payer databases, like the one used in the AHA analysis, are impossibly biased because the sicker patients will always go to Impella,” O’Neill said.