title: HeartSaver VAD: a totally implantable ventricular assist device. Results of in vivo studies.
abstract: Currently, the most widely utilized ventricular assist devices (VADs) require percutaneous connections and are located either externally (e.g., Thoratec, Abiomed) or intra-abdominally (e.g., Novacor, TCI). These attributes have been implicated in a variety of complications (infection, thromboembolic, gastrointestinal, etc.). To address these concerns, a totally implantable VAD that requires no percutaneous connections and can be implanted in the left hemi-thorax has been developed. The developed device has undergone in vivo evaluation as part of the design and development process. A total of 43 implants in the bovine model, with 5 device versions, have been conducted between July 1992 and February 2000. These studies successfully have demonstrated several important aspects of the developed device, including 1) feasibility of a totally implantable system; 2) capability of the device to support a dysfunctional heart; and 3) ability of the device to provide flows up to 10 L/min in a physiological setting. The studies to date have played a vital role in the design and development process as well as demonstrating the feasibility of a totally implantable intrathoracic VAD. Based on these studies, design optimization was conducted, resulting in the development of the pre-clinical version of the device in preparation for clinical trials.
authors.affiliation: Cardiovascular Devices Division, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. tofym@ottawaheart.ca
authors.forename: T
authors.initials: T
authors.lastname: Mussivand
authors.forename: P J
authors.initials: PJ
authors.lastname: Henry
authors.forename: R G
authors.initials: RG
authors.lastname: Masters
authors.forename: W J
authors.initials: WJ
authors.lastname: Keon
mesh_terms: D000818:Animals; D002417:Cattle; D018795:Device Approval; D004567:Electrodes, Implanted; D006353:Heart-Assist Devices; D006801:Humans; D014481:United States