Abiomed Begins Impella RP Trial - Analyst Blog
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 years.
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 Cyberonics ( CYBX ), Given Imaging ( GIVN ) and Cepheid ( CPHD ) are also worth considering. All the 3 stocks carry a Zacks Rank #1 (Strong Buy).
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