Leading provider of heart support technologies, ABIOMED, Inc. (ABMD) secured the CE Mark approval to market its Impella RP (Right Peripheral) heart pump in the European Union. Shares of ABIOMED climbed 2.8% following the announcement last week, to close at $24.48 till the last closing date.
ABIOMED’s Impella RP is a percutaneous heart pump that can be planted into the heart via the femoral artery in the thigh without the need for a surgical procedure. It is designed to access the heart’s right ventricle via the vena cava to provide temporary ventricular support for patients with right ventricular failure.
The device delivers over 4 liters of blood per minute from the lower right atrium to the pulmonary artery. As a result, the Impella RP enables surgeons to treat right ventricular dysfunction in a minimally invasive manner.
Impella RP is the latest in ABIOMED’s line of Impella heart pumps. Impella 2.5, Impella 5.0, Impella CP and Impella LD have already secured the U.S. Food and Drug Administration (:FDA) pre-market approval. The Impella RP, however, is not currently cleared for sale or use in the U.S.
Last month, ABIOMED had announced successful completion of patient enrolment in the Recover Right clinical trial of its Impella RP in the U.S. The company plans to use the results from the trial to apply for a Humanitarian Device Exemption (:HDE) approval, for which it has already received a Humanitarian Use Device (HUD.V) approval in Jul 2012.
Following the commercial European availability of the new Impella RP device, ABIOMED anticipates the FDA go-ahead by Feb 2015. The company plans to introduce this novel product into its established hospital installed base.
ABIOMED is witnessing strong demand for its Impella line of products as an increasing number of patients are being treated with these devices. Impella utilization thus continues to grow at an impressive pace, with the last reported quarter posting double-digit rise in Impella revenues.
ABIOMED presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks worth a look in the medical instruments industry are Syneron Medical Ltd. (ELOS), Delcath Systems, Inc. (DCTH) and Accuray Inc. (ARAY). While Syneron Medical and Delcath Systems sport a Zacks Rank #1 (Strong Buy), Accuray retains a Zacks Rank #2 (Buy).