(ABMD) Abiomed Sees Positive USpella Device Data

Massachusetts-based cardiac assist devices maker Abiomed (ABMD) reported encouraging clinical data from the prophylactic use of its Impella 2.5 cardiac pumps in complex coronary interventions.

Results from the company’s USpella multi-center observational registry, published in the December edition of the Catheterization and Cardiovascular Interventions Journal, showed that patients receiving percutaneous revascularization with Impella 2.5 support achieved a statistically significant improvement in left ventricle ejection fraction (“LVEF”). LVEF is a measure of the amount of blood beingpumped out of the left ventricle (the main pumping chamber) with each beat.

Moreover, there was a considerable improvement of the functional heart failure status in one or more New York Heart Association (“NYHA”) classes (classification representing stages of heart failure). The results further validate the effectiveness and viability of Impella 2.5.

Abiomed recently published new data from the Protect II study at the Transcatheter Cardiovascular Therapeutics (“TCT”) conference, which demonstrated improved outcomes in patients undergoing extensive revascularization with Impella support. The company said that data from the USpella registry are essentially similar to those observed in the Protect II study.

Abiomed enjoys strong demand for its Impella cardiac pumps. Strong Impella sales fueled double-digit revenue growth in second-quarter fiscal 2012. Abiomed is pursuing a number of strategies to boost Impella use.

Utilization of Impella continues to grow at a healthy pace as borne out by the increasing number of patients being treated with the device. Additional data updates on Impella through the remainder of fiscal 2012 are expected to boost the device’s adoption.

While we are upbeat about the prospect of Impella, we remain cautious about the intensely competitive environment and reimbursement risk. Abiomed faces competition from organizations developing permanent heart assist products including Thoratec Corporation (THOR). Our long-term Outperform recommendation on Abiomed is backed by a short-term Zacks #2 Rank (Buy).

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