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Abiomed announced the FDA has granted 510(k) clearance for its low-profile sheath for percutaneous placement of its mechanical circulatory support device used in high-risk patients undergoing PCI.The sheath (Impella Low Profile Sheath) is designed for use with the Impella CP with SmartAssist mechanical circulatory support system, which is approved for use in PCI for patients with advanced HF or ....