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Abiomed Wins IDE Approval

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Leading cardiac assist devices maker, Abiomed Inc. (ABMD - Free Report) 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 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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