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Portable Circulatory Support Driver receives CE Mark approval

Abiomed : 28 March, 2008  (New Product)
Abiomed has received the CE Mark for its Portable Circulatory Support Driver and will now be able to sell the device 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.

The new AB5000 Portable Driver is lightweight, quiet, demonstrates reliable performance, 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.

Abiomed's AB5000 Portable Driver, weighing only 18 pounds, is the lightest and most powerful bi-ventricular system in the industry. The driver delivers the pressures and vacuums equivalent to Abiomed's AB5000 console and its recently approved iPulse combination console. Internal testing of the Portable Driver and the AB5000 Ventricle has demonstrated high reliability.

The testing showed that the Portable Driver is capable of providing full support for a year's intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation, which is estimated to be three times longer than existing portable consoles that weigh twice as much or more.

Abiomed's Portable Driver was designed with the latest smart battery technology for extended power capability and the quiet operation of the Portable Driver provides for minimal disruption of the patient's quality of life at-home. Abiomed recently announced FDA labelling approval of one year bench reliability for its AB5000 VAD, which is expected to complement the Portable Driver reliability.

'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 the Portable Driver will enhance the company's BTT market opportunity.

The US Food and Drug Administration (FDA) has not approved Abiomed's Portable Driver. The company is pursing an investigational device exemption (IDE) to conduct a discharge study, which was submitted in January 2008 for FDA review. The company is currently working to resolve open issues and questions from their response. As proposed, the US study would target 20 transplant hospitals for 30 patients.
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