Jefferies Reiterates Hold Rating on Abiomed (ABMD)
The Jefferies analysts said, “ABMD hosted an investor/analyst day yesterday where physician experts provided a formal update on the USpella registry and reviewed the science and clinical benefit of Impella, while mgmt gave a company update reiterating F11 top line guidance. Though we recognize Impella's strong utilization growth and solid results from the USpella registry, we believe definitive clinical data proving the device's superiority to an intra-aortic balloon pump is essential for cannibalization of a significant portion of the 125K annual IABP procedures and solidify future reimbursement rates.”
They added, “Although this data set was presented at EuroPCR earlier this year, Dr. William O'Neill provided the investment community with a thorough review of the registry and both arms (High Risk PCI (n=178) and AMI Shock (n=43)). The highlights of the data sets included statistically significant improvements in LVEF in the 91 patients available for follow up in the High Risk PCI arm and non- statistically significant improvement in the 23 patients available for follow up in the AMI Shock arm.”
“The importance of improved LVEF includes better QOL due to a relative reduction in NYHA Class III and IV cases and decreased costs (avoidance of an ICD indication). The improvement in LVEF in the High Risk PCI arm was consistent with results from both Protect I (n=16) and a two center Italian registry (n=10). 30-day MACE (7.9%) and mortality (4.5%) in the High Risk PCI group were lower than published rates for High Risk PCI in the clinical literature. Further, Cardiac Power Output, which has been proven to correlate with in-hospital mortality, was significantly improved with the Impella in the AMI shock arm, as was Mean Arterial Blood pressure (n=18). Although the registry data demonstrates undoubtedly strong trends, the "n" needs to get bigger in our view and the data needs to be published to have a greater impact on Impella adoption.”
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