FDA Approves Miniature Blood Pump System For High Risk PCI
On March 23, the U.S. Food and Drug Administration (FDA) approved the Impella 2.5 System for high-risk percutaneous coronary intervention (PCI) procedures, such as balloon angioplasty and stenting. The system functions as a miniature blood pump that aids certain coronary artery disease patients in maintaining a stable heart function and circulation during these procedures. The system is only intended for temporary use and should not be placed in patients who are candidates for surgical coronary bypass treatment. Data from the PROTECT II clinical trial was used by the FDA in determining the approval of the Impella 2.5 System.
Read the FDA's announcement.
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