Abiomed (NSDQ:ABMD) said it plans to ask the FDA to allow more patients to enroll in the Recover Right trial of its Impella RP right-side heart pump, now that it’s met the 30-patient goal for the study.
Danvers, Mass.-based Abiomed said the study is designed to track Impella RP patients for 14 days. Like its 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.
Abiomed won an investigation device exemption from the FDA for the Recover Right trial in 2012, implanting the 1st patient in the spring of 2013. To be eligible for the 2-year study, patients must either develop right-side heart failure within 48 hours after LVAD implantation, after going into shock within 48 hours of heart surgery or after a heart attack.
Today Abiomed said it plans to ask the FDA for a continuous access protocol for the trial’s 15 approved sites "to continue enrolling a limited number of patients that meet the criteria and protocol." Data from the 30 patients already enrolled are slated for submission with Abiomed’s bid for a human device exemption from the FDA, according to a press release.
"We are extremely grateful for the support from the study’s principal investigators, Dr. Mark Anderson, at Einstein Medical Center Philadelphia and Dr. William O’Neill at Henry Ford Hospital, as well as the other investigators involved in this trial," chairman, president & CEO Michael Minogue said in prepared remarks. "The dedication from these investigators has led to the completion of patient enrollment and will enable data analysis and submission for a HDE with anticipated approval in early 2015."
ABMD shares were down 2.0% to $26.22 apiece as of about 1 p.m. today.