Abiomed Trial Discusses Recover Right Trial Results

Abiomed Inc. has revealed clinical trial results from Recover Right, an investigational device exemption (IDE) study of the Impella RP (right percutaneous) system. The clinical trial results demonstrated a survival rate of 73 percent in the overall patient population.

Recover Right was a U.S. Food and Drug Administration (FDA)-approved, prospective, multicenter, single arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support.

The 30 patients enrolled in the Recover Right trial were categorized into two patient cohorts: Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD); Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

Overall, the survival rate was 73 percent in the entire population at 30 days. Cohort A showed a survival rate of 83.3 percent and cohort B had a 58.3 percent survival rate at 30 days.

“Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively. 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 United States,” said William O’Neill, M.D., co-principal investigator for the Recover Right trial and medical director of structural heart disease at Henry Ford Hospital.

“The Impella RP is the first percutaneous, single vascular access pump designed for right heart support. 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 acute patients,” said Michael R. Minogue, Chairman, president and CEO of Abiomed.

“The trial results were favorable and the 30-day outcomes appear promising compared with clinical data from surgical RV assist devices; however our study was not designed for a statistical comparison. Overall, the results show that the percutaneous approach with Impella RP potentially offers significant advantages to patients,” said Mark Anderson, M.D., co-principal investigator for the trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.

The company also announced last week that it has completed its FDA submission of Recover Right trial data for the human device exemption submission.

Based in Danvers, Mass., Abiomed makes medical devices that provide circulatory support.