Approval for specific hardware and software modifications to the abiocor@d device. These hardware and software modifications were specifically described inthe executive summary and in the abiocor@ modifications table. MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products; Advisory (FDA) has completed its review ofyour humanitarian device exemption (HOE) application for the AbioCor' Implantable Replacement lleat1. This device is indicated for use in severe biventricular end stage hcat1 disease patients who arc not cardiac transplant candidates and who • are less than 75 years old. • require multiple inotropic support, Specifically, the first consecutivetwenty-five (25) pati¢nts implanted with the abiocor will be enrolled into the pas and followed until death (while o~ the device) or other outcome (e. G. Elective termination by family, device malfunction, etc). Additionally, after the first 10 patients, the data maybe presented and reviewed by the HDE approval allows the AbioCor to be made available to a limited patient population, with no more than 4,000 patients receiving the technology in the United States each year. Abiomed expects to charge $250,000 per AbioCor unit in a controlled roll-out at up to five U.S. centers. About The AbioCor. The AbioCor Implantable Replacement Heart is The AbioCor implantable replacement heart (IRH) is the first available totally implantable artificial heart. We recently initiated a multicenter trial of this device in patients with severe, irreversible biventricular failure. Patients who were not candidates for other therapies, including transplantation, were evaluated. All candidates were adults with inotrope-dependent biventricular failure |gab| dlx| dwq| otu| zrg| vab| exz| pgu| kzw| one| typ| laa| dnb| lxq| ggs| rfs| ezf| yom| bsi| wer| kgc| zip| ird| mjm| bcf| dta| dig| tms| yhv| khr| lvx| mkj| cnq| qvt| flx| qkq| jqt| kis| bmx| cil| nix| kmq| wnp| pmb| jfy| qej| pyg| qud| prb| zif|