ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group

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” protoc...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Patient Monitoring Replacement Heart Valves Abbott Abiomed Medtronic Source Type: news