), 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.
Edwards Lifesciences Corp.
). While Alphatec Holdings and RTI Surgical sport a Zacks Rank #1
(Strong Buy), Edwards Lifesciences carries a Zacks Rank #2
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