April 2, 2018 — Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The company said these advances in technology and software are designed to improve productivity, ease of use and patient management to ensure optimal patient care.
The addition of Impella CP with SmartAssist includes the following features:
- Simplified patient management: Advanced software and new optical sensor improves understanding of real-time, exact positioning for the Impella heart pump and allows for repositioning without the need for imaging equipment;
- Integration of clinical data informatics on Impella console: Real-time informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP) and cardiac power output (CPO) provides optimal support for patients; and
- Ease of use: Faster setup with fewer steps and connections simplifies patient management for physicians, cath lab staff and ICU staff. New steps further reduce start time by 15 percent, which is critical for emergency patients in cardiogenic shock.
Abiomed has already received CE marking approval in the European Union to market Impella CP with SmartAssist. To date, over 60 patients at three sites have been treated with Impella CP with optical sensor. Abiomed submitted more than 60 engineering reports and full technical specifications for this expanded PMA approval, which were approved by the FDA. To date, the clinical data informatics has been tested on the Abiomed Impella Controller on 38 patients at two hospitals in the U.S.
Over the next fiscal year, Abiomed will launch the Impella CP with SmartAssist through a controlled roll-out at hospital sites with established heart recovery protocols. A simple upgrade to Abiomed’s existing installed base will be performed on the routine service cycle.
“The ability to view fundamental hemodynamic data such as LVP, EDP and CPO directly on the Impella console provides critical information for clinical decision-making,” said William O’Neill, M.D., medical director, Center for Structural Heart Disease, Henry Ford Hospital. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”
The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the ability to enable native heart recovery, allowing patients to return home with their own heart.
The Impella 2.5, Impella CP and Impella CP with SmartAssist, devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries.
Abiomed's right-side heart pump, the Impella RP device, is FDA-approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
For more information: www.abiomed.com
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