ABIOMED, Inc. (ABMD), a leading provider of heart support technologies, announced last week that it has successfully completed the initial 30-patient enrollment in the Recover Right clinical trial of its Impella Right Peripheral (RP) heart pump.
On reaching the enrollment target, ABIOMED plans to submit the compiled data and seek U.S. Food and Drug Administration (:FDA) approval for a Continuous Access Protocol (CAP). The approval would enable the company’s 15 approved Impella RP sites to further enroll a limited number of patients that meet the criteria and protocol for the trial.
Following the announcement, shares of this cardiac assist devices maker rose 2.4% to $26.84 till the last closing date.
Like ABIOMED's previous Impella heart pumps, Impella RP is a percutaneous heart pump that can be implanted into the heart via the femoral artery in the thigh. However, the Impella RP is different from previous Impella devices because it is designed to access the heart's right ventricle via the vena cava while the other devices are designed for the heart's left ventricle.
The device does not require a surgical procedure for insertion, and delivers over 4 liters of blood per minute from the lower right atrium to the pulmonary artery. Therefore, the Impella RP enables surgeons to treat right ventricular dysfunction in a minimally invasive manner.
Impella RP is the latest in ABIOMED’s line of Impella heart pumps. Impella 2.5, Impella 5.0, Impella CP and Impella LD have already secured the FDA pre-market approval.
The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is limited by federal law solely for investigational use.
The Recover Right Trial
The Recover Right clinical study commenced after receiving the FDA IDE approval in Nov 2012. The trial involved evaluating the Impella RP in 30 patients, each of whom demonstrated signs of right side heart failure and required hemodynamic support. They were treated in a catheterization lab, hybrid lab or cardiac surgery suite.
To be eligible for the 2-year study, patients must have developed either right-side heart failure within 48 hours after a LVAD (left ventricular assist device) implantation or post-cardiotomy shock within 2 days of surgery or post myocardial infarction.
ABIOMED plans to use the results from the Recover Right Trial to apply for a Humanitarian Device Exemption (:HDE) approval, for which the company has already received a Humanitarian Use Device (:HUD) approval in Jul 2012. The company further plans to undergo a biventricular “Bridge to Recovery” study in the future involving the Impella RP along with other Impella left-side products.
Moving on, ABIOMED anticipates a CE Mark approval for its Impella RP later this year and the FDA go-ahead by Feb 2015. The company plans to introduce this novel product into its established hospital installed base.
ABIOMED is witnessing strong demand for its Impella line of products as an increasing number of patients are being treated with these devices. Impella utilization thus continues to grow at an impressive pace, with the current quarter reporting double-digit rise in Impella revenues.
ABIOMED presently carries a Zacks Rank #2 (Buy). Medical instrument companies such as Cynosure, Inc. (CYNO), Syneron Medical Ltd. (ELOS) and Natus Medical Inc. (BABY) are also worth considering. While both Cynosure and Syneron Medical carry a Zacks Rank #1 (Strong Buy), Natus Medical holds a Zacks Rank #2 (Buy).