AbioCor Artificial Heart Provides Safety Valve For Increased LVAD Demand
This article was originally published in The Gray Sheet
Executive Summary
AbioMed's AbioCor artificial heart could stimulate demand for left ventricular assist devices (LVADs) by providing a back-up option for patients who fail treatment with the devices.
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AbioMed eventually must show that the AbioCor implantable artificial heart can extend a patient's life at least three years to justify the nearly $300,000 average cost of each implant, according to company consultant Mehmet Oz, MD.
AbioMed AbioCor Artificial Heart Cost Effectiveness Hinges On Longevity
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Arrow's LionHeart
Phase I clinical trials evaluating fully implantable left-ventricular assist system (LVAS) for alternative-to-transplant indication expected to begin by March, firm reports following receipt of investigational device exemption approval. Five-site trial to include up to seven congestive heart failure patients who are not candidates for heart transplant and are refractory to drug therapy. Phase II studies are expected to begin by the end of the firm's fiscal year 2001 (ending Aug. 31, 2001). The firm expects to complete by September a 30 to 40-patient European study to support a CE mark