New studies have shown that the use of percutaneous ventricular assist devices (pVADs) can increase the long-term effectiveness of treatment and decrease the overall costs associated with hemodynamic support procedures. The PROTECT II study, which was instigated by Massachusetts-based Abiomed, was designed to compare the adverse events when using an Impella device versus an intra-aortic balloon pump (IABP) during high-risk percutaneous coronary intervention (PCI) procedures. Though the study ended early, when reviewing first half trial results and assuming trends would continue for the second half, the final results showed that Abiomed’s Impella® device had a 22% reduction in major adverse events when compared to an IABP. A reduction in the need for repeat revascularization was also shown to occur when using an Impella® device with the rate decreasing from 12.4% in IABP to 6% for Impella. For patients that did not undergo an atherectomy procedure (a pre-specified subgroup representing 88% of the total study population), the Impella® device showed a 29% reduction in major adverse events. Those patients enrolled in the study who did not undergo an atherectomy showed no statistical difference in major adverse events after 90 days; however, these patients tended to have a decreased rate of revascularization needed after the procedure

Not only did the study show that the incidence of major adverse events decreased when an Impella® device was used, but overall treatment costs with Impella declined as well over time.

One way to measure the cost-effectiveness of a procedure is to use the incremental cost-effectiveness ratio (ICER), which compares the cost differential between two therapies to the difference in the outcomes generated by the two therapies. The lower the ICER ratio, the more cost-effective the device is. When the 90-day data from the study was projected for ten years, the use of Impella was shown to be cost-effective in comparison to the U.S. cost-effectivess threshold of less than $100,000 per QALY (quality adjusted life year).

The incidence of heart failure in the United States has been on a steady incline since tracking of the disease first began. The American Heart Association estimated that there were 5.7 million people suffering from heart failure in the U.S. in 2011, with approximately 670,000 new cases being diagnosed each year. The increasing size of the patient pool combined with promising clinical trial results has driven strong growth in the U.S. VAD market. Before 2010, the percutaneous VAD device market was estimated to be worth nearly $19 million and was expected to grow at a CAGR of over 19% through 2017. However, the success of Abiomed’s Impella® platform has increased the market far beyond these previous estimates. In Abiomed’s fiscal year 2010, the Impella® platform sold over $50 million in the U.S. alone and exhibited increases of 61.1% and 34.4%, respectively, during its 2011 fiscal year. Current estimates for its 2012 fiscal year are $103 million. These revenues far outpaced previous estimates for this market, and the use of Abiomed’s devices is expected to be the driving force in the percutaneous VAD market in the United States. If Abiomed’s expanded launch of their Impella® platform into Japan and the release of their Symphony™ synchronized cardiac assist device is as successful as their platforms in the U.S., there is great potential for the company to drive growth in the cardiac surgery device markets in the future.

Note: The ACCF/AHA/SCAI PCI guidelines released in November incorporated Impella as Class I recommendation for Cardiogenic Shock, and a new category Class IIb for high risk PCI with the use of hemodynamic support.

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