Back to top

Analyst Blog

Leading cardiac assist devices maker, Abiomed Inc. (ABMD - Analyst Report) commenced its Recovery Right study, which gathers information on the safety and efficacy of the Impella RP (Right Peripheral) device.

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 - Analyst Report), Given Imaging and Cepheid (CPHD - Analyst Report) are also worth considering. All the 3 stocks carry a Zacks Rank #1 (Strong Buy).
 

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
PLANAR SYST… PLNR 4.44 +5.21%
BITAUTO HOL… BITA 81.71 +5.12%
CTPARTNERS… CTP 16.66 +4.26%
CHINA BIOLO… CBPO 47.91 +3.30%
MALLINCKROD… MNK 72.94 +2.85%