Abiomed Wins IDE Approval - Analyst Blog
November 15 2012 - 11:13AM
Zacks
Leading cardiac assist devices maker, Abiomed
Inc. (ABMD) achieved a major milestone by winning the
Investigational Device Exemption (IDE) clearance from the Food
& Drug Administration (FDA) for the use of its Impella RP
(Right-side Percutaneous) in a clinical trial called “Recover
Right”.
The Recover Right clinical study will be headed by Mark Anderson,
M.D., chair of the Division of Cardiothoracic Surgery at Einstein
Healthcare Network and William O'Neill, M.D., medical director of
the Center for Structural Heart Disease at Henry Ford Hospital.
The study is expected to commence in early 2013 and is intended to
gather information on the safety and efficacy of the Impella RP
device. The device will be implanted in 30 patients and will be
monitored for the next 2 years.
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 on
July 13, 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 without
cutting open the patient’s chest.
Massachusetts-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.
However, we are aware of negative sentiments amongst investors
regarding the Impella 2.5 investigation process. In this scenario,
its competitors such as Thoratec Corporation
(THOR) will likely take advantage of the situation and gain market
share. Our Neutral recommendation on the stock carries a short-term
Zacks #3 Rank (Hold) rating.
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