Abiomed (NSDQ:ABMD) said today it is launching its Impella CP with SmartAssist, which won FDA approval last March.
The launch will begin alongside the 2019 Society for Cardiovascular Angiography & Interventions Scientific Sessions which begins on Sunday, the Danvers, Mass.-based company said.
The Impella CP with SmartAssist features improvements intended to simplify patient management, integrate clinical data informatics including left ventricular pressure, end-diastolic pressure and cardiac power output, and improve ease of use during set up and monitoring, Abiomed said.
Abiomed said that during a limited market release over the past year, more than 1,000 patients have been treated with SmartAssist platform.
“Access to real-time clinical data has allowed our team to identify best practices for patient management and weaning. Metrics such as LVEDP, MAP and CPO and the ability to monitor trends on the Impella console allow physicians to utilize this hemodynamic information to optimize heart recovery with objective and quantifiable data to enable clear communication within the shock team,” Hiram Bezerra of Cleveland’s University Hospitals said in a press release.
“The SmartAssist platform represents the next generation of heart recovery products. SmartAssist represents Abiomed’s continued commitment to provide world-class innovation and unparalleled service to help physicians, nurses and ICU staff improve patient outcomes for both survival and native heart recovery,” prez & CEO Michael Minogue said in a prepared statement.
Earlier this week, Abiomed said that it won an expanded indication from the FDA for two of its Impella heart pumps, extending their indwell times from six to 14 days.