Researchers reported an overall 73% 30-day survival rate in the small study of patients with right ventricular heart failure, according to data Abiomed released during the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.
The outcomes "appear promising" when compared with surgical right ventricular devices, but the study wasn’t designed to make a direct comparison between surgical and minimally invasive approaches, the company noted.
The study enrolled patients into two cohorts: those who developed right ventricular failure within 48 hours of receiving a left ventricular assist device (Cohort A) and those that developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction shock (Cohort B).
The former fared better than the latter, with Cohort A patients showing a survival rate of 83.3% and Cohort B patients showing a survival rate of 58.3% at 30 days.
"Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively," co-principal investigator Dr. William O’Neill said in prepared remarks. "The data from this trial is encouraging, and demonstrates that the Impella RP may play a pivotal role in the treatment of RVF patients in need of hemodynamic support in the future here in the U.S."
The results included 30 patients enrolled in Abiomed’s RECOVER RIGHT Investigational Device Exemption study, which is slated to grow after the FDA gave Abiomed approval to expand to include more patients. The Danvers, Mass.-based medical device company met the 30-patient enrollment goal for the study in March, saying at the time that it planned to ask the FDA for permission to enroll more patients. In May Abiomed said the FDA approved a continuous access protocol for the RECOVER RIGHT trial that will allow Abiomed to enroll up 22 more subjects over 6 months
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.
Abiomed’s shares jumped 2.3% today, trading at $25.42 as of about 12:55 p.m. EST. The stock has lost 5% since the start of this year.
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