ABMD - Abiomed's Impella low profile sheath gets FDA clearance

• The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Abiomed's ( NASDAQ: ABMD ) Impella Low Profile Sheath.
• Compared to the existing 14 French (Fr) sheath used for placement Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2 Fr, the company said in a statement on Monday.
• Abiomed added that due to its smaller size and other advancements, the Low Profile Sheath will facilitate easier Impella insertion and removal, and reduce procedural steps.
• The company said that it will begin a phased roll-out of the Impella Low Profile Sheath this quarter.
• The heart pump Impella CP with SmartAssist is approved to treat certain patients with advanced heart failure who are undergoing percutaneous coronary interventions, such as stenting or balloon angioplasty, to reopen blocked coronary arteries, according to the company.

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