Abiomed’s Impella Low Profile Sheath Cleared

Abiomed has received 510(k) clearance from the FDA for its Impella low profile sheath for easier insertion and removal of its Impella heart pump.

The Impella pump is inserted through a small incision and advanced through the arteries into the heart where it pulls blood from the left ventricle and releases it into the aorta.

The new sheath has a smaller outer diameter than the company’s Impella CP tool but has the same inner diameter. The low-profile device will help minimize vascular complications and bleeding, the company said.

Abiomed plans a phased U.S. rollout of the device in the current quarter.