The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at follow up. The interim analysis was presented today by Mitul Patel, MD, an interventional cardiologist at UC San Diego Health, at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation.
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Figure 1 (Graphic: Business Wire)
The ongoing, multi-center, prospective, single-arm study enrolled 193 consecutive qualified patients who underwent a Protected PCI procedure with Impella between September 2019 and September 2020 at 19 hospitals in the United States, representing a variety of hospital settings including rural, urban, community and academic centers. The interim analysis showed:
Significant median LVEF improvement from baseline to 90-day follow up (31% to 45%