Abiomed (NSDQ:ABMD) said it’s won a nod from the FDA to run a clinical trial of its new heart pump for right-side cardiac assistance, the Impella RP.
Like Abiomed’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.*
The 2-year, 30-patient Recover Right trial is expected to launch in early 2013, according to a press release.
"This FDA IDE approval for our Impella RP is a major milestone for the company and we look forward to collecting data on this unique patient population with an unmet medical need," chairman, president & CEO Michael Minogue said in prepared remarks.
Patients right side heart failure requiring hemodynamic support and catheterization lab or cardiac surgery treatment will be enrolled in Recover Right, which Abiomed hopes to use to back a Humanitarian Device Exemption from the federal watchdog agency.
Abiomed said it’s also planning a "bridge-to-recovery" study examining bi-ventricular therapy using the Impella RP and the Impella left-side devices, according to the release.
*Correction, Nov. 15, 2012: This article incorrectly stated the route the Impella RP uses to access the right ventricle. Return to the corrected sentence.
