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Portable circulatory support driver receives CE Mark

Abiomed : 03 April, 2008  (New Product)
Abiomed has received CE Mark approval for its Portable Circulatory Support Driver which enables the device to be sold in all European Union countries as well as many other countries worldwide that accept this approval for registration.
The Portable Driver is designed to support Abiomed's AB5000 Ventricular Assist Device (VAD) for both in-hospital and out-of-hospital patients.

Abiomed’s new AB5000 Portable Driver is lightweight, quiet, reliable and has the potential to improve patient care while lowering costs to hospitals. The AB5000 Portable Driver provides patients requiring VAD support a greater degree of mobility and improved quality of life during treatment aimed at myocardial recovery.

The BVS and AB5000 have exclusive US approvals for all heart recovery indications, and have collectively supported more than 10,000 patients worldwide.

'There is a clinical and financial demand for a highly reliable mobile driver that allows for patient discharge. We are now offering each heart hospital a complete portfolio of circulatory care products that help the heart recover, from the cath lab to the surgery suite to the ICU to home discharge,' said Michael R Minogue, chairman, chief executive officer and president of Abiomed.

The AB5000 VAD is approved in Europe under CE-mark and has supported patients for up to 312 days. Outside of the USA, the AB5000 is used as a bridge-to-recovery (BTR) and bridge-to-transplant (BTT) device, and Abiomed said that the Portable Driver is expected to greatly enhance its BTT market opportunity.

Abiomed's Portable Driver has not been approved by the US Food and Drug Administration (FDA). The company is pursuing an investigational device exemption (IDE) to conduct a discharge study, which was submitted in January 2008 for FDA review.
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