), a leading provider of heart support technologies, announced
last week that it has successfully completed the initial
30-patient enrollment in the Recover Right clinical trial of its
Impella Right Peripheral (RP) heart pump.
On reaching the enrollment target, ABIOMED plans to submit the
compiled data and seek U.S. Food and Drug Administration (FDA)
approval for a Continuous Access Protocol (CAP). The approval
would enable the company's 15 approved Impella RP sites to
further enroll a limited number of patients that meet the
criteria and protocol for the trial.
Following the announcement, shares of this cardiac assist devices
maker rose 2.4% to $26.84 till the last closing date.
Like ABIOMED's previous Impella heart pumps, Impella RP is a
percutaneous heart pump that can be implanted into the heart via
the femoral artery in the thigh. However, the Impella RP is
different from previous Impella devices because it is designed to
access the heart's right ventricle via the vena cava while the
other devices are designed for the heart's left ventricle.
The device does not require a surgical procedure for insertion,
and delivers over 4 liters of blood per minute from the lower
right atrium to the pulmonary artery. Therefore, 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 FDA pre-market approval.
The Impella RP is currently the subject of an investigational
device exemption (IDE) clinical study and is limited by federal
law solely for investigational use.
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The Recover Right Trial
The Recover Right clinical study commenced after receiving the
FDA IDE approval in Nov 2012. The trial involved evaluating
the Impella RP in 30 patients, each of whom demonstrated signs of
right side heart failure and required hemodynamic support. They
were treated in a catheterization lab, hybrid lab or cardiac
To be eligible for the 2-year study, patients must have developed
either right-side heart failure within 48 hours after a LVAD
(left ventricular assist device) implantation or post-cardiotomy
shock within 2 days of surgery or post myocardial infarction.
ABIOMED plans to use the results from the Recover Right Trial to
apply for a Humanitarian Device Exemption (HDE) approval, for
which the company has already received a Humanitarian Use Device
(HUD) approval in Jul 2012. The company further plans to undergo
a biventricular "Bridge to Recovery" study in the future
involving the Impella RP along with other Impella left-side
Moving on, ABIOMED anticipates a CE Mark approval for its Impella
RP later this year and 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 current quarter reporting
double-digit rise in Impella revenues.
ABIOMED presently carries a Zacks Rank #2 (Buy). Medical
instrument companies such as
Syneron Medical Ltd.
Natus Medical Inc.
) are also worth considering. While both Cynosure and Syneron
Medical carry a Zacks Rank #1 (Strong Buy), Natus Medical holds a
Zacks Rank #2 (Buy).