Abiomed’s Impella Low Profile Sheath Granted FDA Clearance

October 17, 2022—Abiomed announced FDA 510(k) clearance for its Impella Low Profile sheath. The company will begin a phased roll-out of the Impella Low Profile sheath this quarter.

According to the company, the Low Profile sheath is specifically engineered to be compatible with the Impella single-access technique, which removes the need for an additional access site.

Compared to the company’s 14-F sheath used for placement of the Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by approximately 2 F. With its smaller size and other technological advancements, the Low Profile sheath will facilitate easier Impella insertion and removal, reduce procedural steps. and help improve outcomes, stated Abiomed.

Additionally, the company noted that the device is designed to achieve the following:

• Simplify access and ease-of-use by eliminating the peel-away sheath and the need for the reaccess sheath for patients who are sent to the intensive care unit
• Further minimize vascular complications and bleeding
• Facilitate easier delivery into the vasculature with a hydrophilic coated long-taper dilator, reducing the need for multiple steps of serial dilation
• Facilitate easier management of the patient during heart pump removal and vascular closure because Impella can be removed directly from the sheath without rewiring

Abiomed’s Impella CP with SmartAssist is FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions. The Impella CP with SmartAssist and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and enable native heart recovery, advised the company.