title: Ten-year NEDO BVAD development program: moving forward to the clinical arena.
abstract: Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.
authors.affiliation: Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Motomura
authors.forename: Hisashi
authors.initials: H
authors.lastname: Okubo
authors.forename: Takeshi
authors.initials: T
authors.lastname: Oda
authors.forename: Daisuke
authors.initials: D
authors.lastname: Ogawa
authors.forename: Toshiya
authors.initials: T
authors.lastname: Okahisa
authors.forename: Stephen
authors.initials: S
authors.lastname: Igo
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Shinohara
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Chikaya
authors.initials: C
authors.lastname: Noguchi
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Ishizuka
authors.forename: Eiji
authors.initials: E
authors.lastname: Okamoto
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Nosé
mesh_terms: D000818:Animals; D001243:Assisted Circulation / Q000295:instrumentation*; D001672:Biocompatible Materials; D001698:Biomedical Engineering; D002417:Cattle; D002498:Centrifugation; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D006354:Heart, Artificial; D006353:Heart-Assist Devices; D006461:Hemolysis; D006801:Humans; D008422:Materials Testing; D008904:Miniaturization; D008955:Models, Cardiovascular; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D013499:Surface Properties; D014025:Titanium
chemical_list: D001672:Biocompatible Materials; D014025:Titanium