Leading cardiac assist devices maker,
) commenced its Recovery Right study, which gathers information
on the safety and efficacy of the Impella RP (Right Peripheral)
This landmark study has been initiated to derive results from
patients suffering from failure in the right side of the heart
following either a left ventricular assist device (LVAD)
implantation or post-cardiotomy shock within 2 days of surgery or
post myocardial infarction. The Impella RP device will be
implanted in 30 patients and will be monitored for the next 2
Abiomed has already received the Investigational Device Exemption
(IDE) clearance from the Food & Drug Administration (FDA) for
the use of Impella RP (Right-side Percutaneous) in the clinical
trial in Nov 2012. Results from the study will be used by Abiomed
to apply for a Humanitarian Device Exemption (HDE) approval, for
which the company has already received a HUD (Humanitarian Use
Device) approval in Jul 2012.
However, this product has not yet been approved by the FDA for
sale in the U.S. The company further plans to undergo a
biventricular "Bridge to Recovery" study in the future with the
Impella RP along with other Impella left-side products.
Impella RP has been designed as a support for right ventricular
dysfunction (right heart failure), which is characterized by the
inability of the right side of the heart to adequately pump
blood, resulting in accumulation of fluids in the body. Impella
RP provides the flow and pressure necessary to compensate for
right heart failure.
The device is inserted percutaneously (via the skin) into the
heart's right ventricle and delivers more than four liters of
blood from the lower right atrium to the pulmonary artery. The
Impella RP enables surgeons to treat right ventricular
dysfunction in a minimally invasive manner.
Mass.-based Abiomed is engaged in developing, manufacturing and
marketing of medical products designed to assist or replace the
pumping function of the failing heart. The company is enjoying
strong demand for its Impella products. Impella utilization
continues to grow at a healthy pace, as is evident from the
increasing number of patients being treated with the device.
Abiomed currently carries a Zacks Rank #2 (Buy). Medical
instrument companies such as
) are also worth considering. All the 3 stocks carry a Zacks Rank
#1 (Strong Buy).
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