Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.
Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said.
The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.
Abiomed said that it met with the FDA who confirmed the classification of patients treated with the Impella RP into two categories: patients treated under the “Recover Right” protocol, which follows inclusion and exclusion criteria used in the company’s premarket approval study of the device, and “salvage support” patients, or those who have experienced more than 48 hours in cardiogenic shock from right side failure.
“When a patient is in right heart failure, Impella RP allows the heart to rest and recovers the heart’s ability to pump blood. The Impella RP is an effective treatment for patients who receive a timely implant and meet the Recover Right inclusion and exclusion criteria,” Dr. David Wohns of Spectrum Health said in a prepared statement.
When separated into categories, Abiomed said that patients under the “Recover Right” protocol had survival rates of 64%, while those classified as “salvage support” had only an 11% survival rate.
The population of “salvage support” patients was 28, while only 14 patients fall under the “Recover Right” protocol, Abiomed said. Data from Abiomed’s PMA Impella RP study indicated a survival rate of 73%.
“The post-approval study data is analogous to our own independent data from multiple hospitals in the Cardiogenic Shock Working Group, which found an approximate 80% survival rate when the Impella RP was used in cardiogenic shock patients who met inclusion criteria from the Recover Right Study. Data like these highlight how the use of algorithms to recognize right sided failure and protocols for early hemodynamic support can help improve outcomes for cardiogenic shock patients,” Dr. Navin Kapur of Tufts Medical Center’s CardioVascular Center for Research and Innovation said in a prepared release.
The company said that the Impella RP is the only device submitting post-approval study data on real-world patient outcomes, including salvage utilization, and that its patient population will continue to be studied in the ongoing cVAD study.
Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.