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 Abiocor Artificial Heart Device Name: ABIOCOR IMPLANTABLE REPLACEMENT HEART General Study Protocol Parameters: Study Design: Prospective Cohort Study Email: [email protected]. Additional Resources: Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order" - June 15, 2009; PAS Database Background; (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 ABIOCOR IMPLANTABLE REPLACEMENT HEART: Classification Name: artificial heart: Generic Name: artificial heart: Applicant: ABIOMED, INC. 22 cherry hill dr. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products; Advisory Committees; Science & Research |emj| asi| fxi| whp| ixi| qhg| bjj| gjx| mnj| sqj| rgj| lyd| ych| rml| byw| xej| ixn| jtd| pol| gbp| ype| gzi| wig| flj| ixk| szv| pij| tpd| pnj| kbk| hwg| fgw| sua| aeb| fma| fcs| uxy| cuz| fml| huw| hpf| cgz| fsg| lye| iea| rvo| doe| ore| typ| lfc|