Impella CP heart pump with SmartAssist is FDA approved for ventricular support.- AbioMed Inc.

Abiomed, Inc. announced that it has received FDA Pre-Market Approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. At the forefront of innovation, 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 represents the next generation for heart recovery products and includes the following features: 1. 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.2. 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. 3.Ease of Use: Faster set-up with fewer steps and connections simplifies patient management for physicians, cath lab staff and ICU staff. New steps further reduce start time by 15%, 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.