ABIOMED, Inc. (ABMD - Free Report) , a leading provider of heart support technologies, reported the implantation of over 20,000 Impella heart pumps in the U.S. The Impella heart pump is the company’s flagship product for patients in need of hemodynamic support.
The 20,000th procedure took place at Keck Medicine of University of Southern California (USC) hospital. Integrated into this hospital’s program, the Impella platform is considered a necessary tool for offering a full spectrum of hemodynamic support to patients with minimally invasive procedures.
To date, the higher flow Impella CP has been implanted in over 3,000 U.S. patients, with the 3,000th procedure being carried out at the Hoag Memorial Hospital Presbyterian.
ABIOMED’s Impella heart pump is a percutaneous pump that can be planted into the heart via the femoral artery in the thigh without the need for a surgical procedure. It enables surgeons to treat ventricular dysfunction through minimal invasion.
The Impella platform consists of the Impella 2.5, Impella CP and Impella 5.0 heart pumps, all of which currently enjoy U.S. Food & Drug Administration (FDA) clearance for partial to full circulatory support for up to six hours.
The addition of the Impella RP (Right Peripheral) completes the Impella platform and allows it to offer a full range of hemodynamic procedures. Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is solely limited to investigational use by the federal law.
ABIOMED recently secured CE Mark approval for Impella RP in the EU, following which it anticipates the FDA go-ahead for this novel product in early 2015.
In Mar 2014, ABIOMED announced the successful completion of initial patient enrollment in the RECOVER RIGHT clinical trial of its Impella RP. More recently, the company received an extended Continuous Access Protocol (CAP) to allow it to register an additional 22 patients into the trial for further evaluation.
ABIOMED is witnessing strong demand for its Impella line of products. With the last reported quarter clocking a double-digit rise in Impella revenues, Impella utilization continues to grow at a remarkable pace.
Furthermore, with an ageing population, ABIOMED expects the Impella platform to become the standard of care for biventricular percutaneous circulatory support.
ABIOMED currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the medical instruments industry are Alphatec Holdings, Inc. , RTI Surgical Inc. (RTIX - Free Report) and Edwards Lifesciences Corp. (EW - Free Report) . While Alphatec Holdings and RTI Surgical sport a Zacks Rank #1 (Strong Buy), Edwards Lifesciences carries a Zacks Rank #2 (Buy).