US-based medical implant devices manufacturer Abiomed has announced the commercial availability of its Impella CP along with SmartAssist, designed to improve patient outcomes with advanced algorithms and simplified patient management.
Abiomed unveils the commercial availability at 2019 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions through a controlled launch process at select sites.
In addition, the company would switch the majority of Impella CP heart pumps in the US to SmartAssist over the next fiscal year.
In March 2018, Abiomed has secured US FDA approval for Impella CP with SmartAssist, and executed a limited market release in the last year, where more than 1,000 patients at 70 sites have been treated with the SmartAssist platform.
Abiomed said that the advances in Impella forward-flow heart pump technologies and software are designed to improve ease-of-use and patient management to optimize both survival and heart recovery.
The advances include weaning algorithms to optimize survival and native heart recovery, which provides real-time display of critical hemodynamic metrics including left ventricular end-diastolic pressure (LVEDP), mean arterial pressure (MAP), and cardiac power output (CPO).
The company claimed that Impella CP with SmartAssist marks the only mechanical circulatory support device to calculate and display LVEDP, MAP and CPO.
In addition, the device offers easier management and repositioning, where SmartAssist sensor allows precise positioning in the aorta and left ventricle and repositioning in the ICU without the need for catheterization lab or ultrasound imaging.
Cleveland University Hospitals interventional cardiologist Hiram Bezerra said: “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.”
Abiomed said that its SmartAssist platform is complemented by on-site and on-call support, including the clinical support center that provides 24×7 expert evaluations of Impella data and collaborative patient care to help improve outcomes.
Abiomed chairman, president and CEO Michael R. Minogue said: “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.”