ABIOMED, Inc. (ABMD), a leading provider of heart support technologies, posted results from the Recover Right clinical trial of its Impella Right Peripheral (RP) heart pump, demonstrating a 73% survival rate in the overall patient population.
Shares of ABIOMED climbed roughly 0.7% in the trading session following the announcement of the favorable trial results.
The Recover Right Trial
The Recover Right clinical study commenced after receiving the Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in Nov 2012. The prospective, multi-center, single arm study was designed to evaluate the safety and probable benefit of ABIOMED’s Impella RP in patients who demonstrated right ventricular failure (RVF) refractory to medical treatment, and required hemodynamic support.
The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy. Data gathered at the end of the 30-day trial was encouraging and exhibited the high potential of Impella RP in the treatment of RVF patients.
Impella RP
ABIOMED’s Impella RP is a percutaneous heart pump that can be planted in the heart via the femoral artery in the thigh without the need for a surgical procedure. It is designed to access the heart’s right ventricle through the vena cava to provide temporary ventricular support for patients with RVF.
Impella RP is the latest in ABIOMED’s line of Impella heart pumps, which consists of Impella 2.5, Impella 5.0, Impella CP and Impella LD.
The pump is designed to be used concurrently with other left ventricle pumps in the Impella platform, which in the future may offer physicians the option of percutaneous biventricular support for serious patients.
Impella RP is currently the subject of an IDE clinical study and is solely limited to investigational use by the federal law. Though the device is not currently cleared for sale or use in the U.S., ABIOMED secured CE Mark approval for Impella RP in April this year. Following the commercial European availability of the new Impella RP device, ABIOMED expects the FDA go-ahead by early 2015.
ABIOMED also announced last week that it has completed the submission of Recover Right trial data to the FDA for the Human Device Exemption (HDE) approval and anticipates the same by Mar 2015.
Zacks Rank
Currently, ABIOMED carries a Zacks Rank #4 (Sell). Better-ranked medical instrument stocks include Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB) and RTI Surgical Inc. (RTIX). All these stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment