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FDA Approves Miniature Blood Pump System

Device intended for certain patients undergoing surgery for severe CAD

The FDA has approved the Impella 2.5 system (Abiomed, Inc.), a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked because of severe coronary artery disease (CAD).

The Impella 2.5 system is a heart pump intended for temporary use by patients with severe symptomatic CAD and diminished (but stable) heart function who are undergoing HRPCI procedures but are not candidates for surgical coronary bypass treatment. In patients with diminished heart function, the heart pumps less blood than normal every time it beats, which is sometimes associated with CAD.

Throughout an HRPCI procedure, the Impella 2.5 system helps maintain stable heart function by drawing blood from the left ventricle and pumping it into the aorta. Before starting a procedure, the interventional cardiologist places the Impella 2.5 using a catheter with the pump loaded into the tip. The heart is accessed by inserting the catheter into one of the body’s large arteries, usually in the leg, and then guiding the tip of the catheter through the patient’s arteries and into the left ventricle. Once the pump is in place, an external controller and monitor turns it on and off, measures heart function, and allows health care providers to adjust the pump as necessary to maintain stable heart function and circulation during the procedure.

All patients undergoing HRPCI are at risk for complications related to decreased heart function and lowered blood pressure during the procedure, but patients in need of treatment for extensive or critically located CAD who are already experiencing diminished heart function are at high risk. Unstable heart function that occurs during an HRPCI procedure can result in serious complications or can prevent completion of the procedure.

The FDA reviewed data for the Impella 2.5 system in a premarket approval application, the agency’s pathway to evaluate a reasonable assurance of safety and effectiveness for class III medical devices. Data supporting the approval of the Impella 2.5 system included clinical results from the manufacturer’s PROTECT II trial, with supporting information from the USpella Registry, a multicenter, observational registry.

The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 system during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation and low blood pressure) due to temporary abnormalities in heart function. Moreover, fewer later adverse events, such as the need for repeat HRPCI procedures, may occur in patients undergoing HRCPI with the pump compared with patients undergoing HRPCI with an intra-aortic balloon pump (IABP).

The Impella 2.5 system can be used as an alternative to the IABP without significantly increasing the safety risks of the HRPCI procedure, the FDA says.

Source: FDA; March 24, 2015.

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